Inspections, Compliance, Enforcement, and Criminal Investigations

Childrens Medical Ventures 8/8/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
14-PHI-18
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
 
       August 8, 2014
 
 
Mr. Chris A. Ferguson, Director Quality and Regulatory
Children’s Medical Ventures/Philips Healthcare
3000 Minuteman Drive
Andover, MA 01810
 
Dear Mr.  Ferguson:
 
During an inspection of your firm previously located at 191 Wyngate Drive, Monroeville, PA, conducted between March 10, 2014 and March 28, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the SmartMonitor 2 PS. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), the SmartMonitor 2 PS is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.
 
Quality System Violations
 
This inspection revealed that your device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), for medical devices in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
 
We received your responses dated April 16, 2014 and April 29, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to the following:
 
1. You failed to establish and maintain procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90 (a). Specifically,
 
Your CAPA # (b)(4), dated 12/11/13, and your “Post Market Risk Assessment Form”, dated 10/30/2013, with Ref # (b)(4), and “Field Action Decision Form”, dated 11/12/2013, with Unique ID #(b)(4), document that through complaint investigations, a wiring issue was discovered with 311 SM2PS battery packs for SmartMonitor 2 PS devices, which resulted in device failures causing the units to constantly alarm, not allowing continuous monitoring of respiration, heart rate, and oxygen saturation of infant patients, as intended. Two hundred battery packs, encoded with lot # (b)(4), and (111) battery packs, encoded with lot # (b)(4), all identified with material # (b)(4), were incorrectly wired and used as a component in the manufacture of SmartMonitor 2 PS devices and/or sold separately as replacement stock for SmartMonitor 2 PS devices. CAPA #(b)(4), dated 12/11/13, “Post Market Risk Assessment Form”, dated 10/30/2013, with Ref # (b)(4), and “Field Action Decision Form”, dated 11/12/2013, with Unique ID # (b)(4) also documents that no Health Hazard Evaluation or risk reduction activities were performed.
 
All (311) affected SmartMonitor 2 PS devices and/or battery pack replacement stock were distributed as follows:
 
-    (168) affected units were quarantined at a (b)(4) distribution center and/or the Philips contract manufacturer.
-    (143) affected units were distributed to the field. Seventeen (17) of these units have been accounted for through consumer complaints, and (27) of these units have been accounted for through service work orders. As of 03/13/2014, (99) of the (143) affected units distributed to the field have not been controlled, removed, or corrected.
 
Your responses dated April 16, 2014 and April 29, 2014, appear to be adequate, and corrections will be verified during your next inspection.
 
2. Complaint files are not adequately maintained as required by 21 CFR 820.198 (a). Specifically,
 
Twenty seven (27) service work orders initiated by Field Change Order with FCO reference #(b)(4), were not maintained as complaint files.
 
Your responses dated April 16, 2014 and April 29, 2014, appear to be adequate, and corrections will be verified during your next inspection.
 
MDR Violations
 
Our inspection also revealed that your devices are misbranded under Section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under Section 519 of the Act, 21 USC 360i, 21 CFR Part 806 – Reports of Corrections and Removals Regulation.
 
3. You failed to keep a copy of all communications regarding the correction or removal as required by 21 CFR 806.20(b)(5). Specifically,
 
Your (311) SmartMonitor 2 PS devices and/or SM2PS battery pack replacement components were found to have a wiring issue resulting in device failures causing the units to constantly alarm, not allowing continuous monitoring of respiration, heart rate, and oxygen saturation of infant patients, as intended. Field Change Order with FCO Reference # (b)(4) documents a "retrofit on failure" field correction is instructed to be performed on all (311) affected units, which was not reported in writing to FDA.
 
Your responses dated April 16, 2014 and April 29, 2014, appear to be adequate, and corrections will be verified during your next inspection.
                                                                                                                                                                    
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Additionally, federal agencies may be advised of the issuance of 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) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
 
Your written response should be sent to Yvette I. Johnson, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Johnson at (215) 717-3077 or e-mail at Yvette.Johnson@fda.hhs.gov.
 
                                                                                               
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District

Page Last Updated: 08/25/2014
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