Inspections, Compliance, Enforcement, and Criminal Investigations
Heartsine Technologies Inc 12/10/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
December 10, 2009
VIA FEDERAL EXPRESS
Mr. Gregory Cash
President and CEO
Heartsine Technologies Inc.
3131Excelsior Boulevard #413
Minneapolis, MN 55416
Dear Mr. Cash:
During an inspection of your firm located in Newtown, Pemlsylvania from July 23, 2009, through August 4,2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class III Automatic External Defibrillator (AED) devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
The inspection revealed that your AED devices are misbranded within the meaning of Section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519(e) of the Act, 21 U.S.C. 360e and 21 C.F.R. Part 821 - Medical Device Tracking Requirements. Significant deviations include, but are not limited to, the following:
1. Failure to keep current records containing information, such as name, address, and telephone number of the distributor, patient, or prescribing physician along with the lot number, batch number, or the serial number of-the device, on each tracked device released for distribution, as required by 21 C.F.R. 821.25(b). For example, your firm was unable to produce tracking information for (b)(4) devices that are subject to medical device tracking requirements that was requested for review at the inspection. Also, your firm's tracking procedure, Tracking of Medical Devices, document no. (b)(4) only requires distributors to collect required tracking information and provide the information upon the firm's request, rather than upon receipt of the device.
2. Failure to establish a data collection and recording procedure for recording when tracking data is missing and cannot be collected and include the reason why such required data is missing and cannot be collected, as required by 21 C.F.R. 821.25(c)(1). For example, your firm's tracking procedure, Tracking of Medical Devices, document no. (b)(4) does not include a data collection and recording procedure for recording when tracking data is missing and cannot be collected and the reason why such required data cannot be collected.
3. Failure to conduct tracking system audits at intervals not greater than once every six months for the first three years of distribution and at least once a year thereafter based on a statistically relevant sampling of tracking records, as required by 21 C.F.R. 821.25(c)(3). For example, the documents provided during the inspection indicate that the last audit was performed on (b)(4) Tracking regulations require that a subsequent audit must have occurred within a period of not greater than one year, in this case (b)(4). However, a subsequent tracking system audit has not been conducted as of (b)(4), when the FDA had begun its inspection.
Our inspection also revealed that your AED devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to conduct an investigation of each event and evaluate the cause of the event, as required by 21 C.F.R. 803.50(b)(3). For example:
a. The technical support request file no (b)(4) dated (b)(4), describes an event where a unit issued a low battery warning and did not provide a shock when used in an event involving a 90 year old female patient. Additional comments indicate that the investigation was based on the event log that indicated that a low battery warning was issued. However, the event log does not document any investigation to determine the cause of the low battery warning.
b. The service request (b)(4), dated (b)(4) describes an event where a unit advised no shock on a patient when no pulse was detected. A second defibrillator used by the EMT personnel advised the shock. The user indicated that the AED kept issuing the pull green tab prompt even though pads had been applied. Documentation does not indicate any investigation to determine the cause for the AED to keep issuing pull green tab prompt.
2. Failures to develop, maintain, and implement a written MDR procedure, as required by 21 C.F.R. 803.17. For example:
a. Section 5-9 of your MDR procedure, document no. (b)(4), defines the term "becomes aware." This definition, however, is not consistent with the language in 21 C.F.R. 803.3.
b. Your MDR procedure lacks clarity about the roles and responsibilities for your MDR reporting decision-making and record-keeping, See 21 C.F.R. 803.17.
c. Your MDR procedure does not adequately address who makes the final determination of whether an event must be reported as an MDR to FDA and when or how MDR events are detected.
d. Your MDR procedure lacks information about the requirements for establishing and maintaining MDR files or records. See 21 C.F.R. 803.18
Your response dated August 12, 2009, to the FDA-483 issued August 4, 2009, appears to be adequate. A follow up inspection will be required to assure that corrections are adequate.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to,seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: James C. Illuminati, Compliance Officer at the address above. If you have any questions about the content of this letter please contact: James C. Illuminati at (215) 717-3078 or fax (215) 597-8212.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Kirk D. Sooter
Pennsylvania State Department of Health
132 Kline Plaza, Suite A
Harrisburg, PA 17104
Attention: Director, Division of Primary Care and Home Health Services
Heartsine Technologies Inc.
121 Friends Lane
Newtown, PA 18940