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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cardiac Science Corp. Response Summary

 

FDA Warning Letter 2/5/10
Cardiac Science Response Summary

No. Description of Cite Cardiac Science Response Summary Follow-on Action
1(a)

Resistor failures in distributed product

• No corrective action identified

• Software update inadequate

• 806 Package filed with FDA on 11/13/09 describing field corrective action process including customer notification plan

• Software update enhances device self-test capability to identify resistor failures including (b)(4) and activate red RescueReady® indicator and/or audible alarm

• Software installation through download or CD kit
• Reliability analysis demonstrating that failure during rescue will improve from a prediction of 1 to 1(b)(4)

• Devices that ail self-test will be returned and repaired as part of normal service return process

Continue implementation of the field correction software update

 

1(b)

(b)(4) Relay failures in distributed product

• No corrective action identified

• Software update inadequate

• 806 Package filed with FDA on 12/16/10 describing field correction action process including customer notification plan

• All failures were caught during self-test and none associated with patient rescue
• Failures were the result of manufacturing defect that failed within first 200 days device put into service;

• Relays that are not part of the infant failure population have demonstrated a 15,000 day wear-out period
• Notified customers for 332 devices that fell within the 200 day period that this failure could occur reminding them of importance of performing self-test according to IFU
• Software enhancement update includes the capability to detect a relay failure and activate red RescueReady@ indicator and/or audible alarm

Follow-up on request for close-out of Field Correction submitted to FDA on 2/15/10

 

Continue implementation of software enhancement update as part of the resistor action

 

1(c)

Effectiveness of software changes for (b)(4)

 

Lack of documentation to demonstrate effectiveness of the corrective action

 

• Incident identified in the Warning Letter failed prior to receiving the updated software fix so is inappropriately identified as a post-fix failure

• The device had a failed capacitor which was correctly identified during self-test as a failure

• The device was returned and service replaced the bad component and installed the new software
• There have been no false (b)(4) field failures for devices that have received the software update correction
• Field Corrective Action progress reports for recalls Z-0916/0922-2009 regularly provided to FDA

No further action required
2(a) and (b) Failure Investigation Process procedure DI-00039-01 does not describe when a failure investigation should be initiated or when a rationale for no investigation should be documented

• SOP-00012-01 Complaint Process and Reporting discusses when a failure investigation should be initiated and when a rationale for no investigation should be documented.

• This information was in the SOP-00012-01 revision in place at the time of the inspection and provided to the investigators. It is also present in the current revision updated on 11/12/09 and was present in the initial 10/6/06 release of the procedure
• DI-00039-01 is a lower level document called out by SOP-00012-01 which describes how to complete an investigation. The DI is not intended to describe when an investigation is to be completed which is appropriately covered in the upper level SOP.

No further action required
3(a)

CAPA procedure does not indicate that short term and long-term actions should be verified and/or validated and that such activities should be documented

 

• Verification/Validation activities are part of the SOP-0007-01 Product Development Process and SOP-0009-01 Manufacturing process control subsystems
• CAPA system reengineering planned for completion 3/31/10. Actions already taken are;

o Corporate level CAPA Board

o New procedures to assess nonconformance for CAPA assignment based on risk

(b)(4) CAPA module scheduled go-live 3/31/10

Continue reengineering of CAPA process and implementation of (b)(4) CAPA module and reengineered process; both to be completed 3/31/10

3(b) Lack of evidence of approval of (b)(4) resistor screening fixture

• Approval of fixture by CSC completed on 10/23/09

• DI-00107-01 Product Test Fixture and System Documentation was updated on 10/20/09 to Rev B to include the requirements for reviewing and approving 3rd party fixturing before being placed into production and used on CSC products.

• The procedure was added to the QA training matrix and training completed and documented for the identified personnel involved in its execution

No further action required
4(a)
and
(b)
Procedures do not ensure that the
design requirements are appropriate and address the intended use. In addition, procedures do not adequately address the process for ensuring that incomplete, ambiguous or conflicting requirements are resolved.
• 102-0083 rev A does not adequately define three year operating life under normal use conditions for the battery
• DHF-00048-01 defines the physical battery operating specifications
as 0°C to 50°C and the electrical battery operating specifications as 25°C

• Specifications for all battery types were reviewed and updated including (b)(4) and rechargeable
• 102-0083 Rev A was updated to Rev B on 12/3/09 on DC-00224. The battery specification was updated to include:

o the operating, short and long temp storage and temperature conditions
• DHF-00048-01 Rev B was updated to Rev C on 11/13/09 on DC-00217 and subsequently to Rev D on 1/13/10 on DC-00324. The battery spec was updated to include:

o The minimum operating time and number of shocks consistent with the operating
temperature range and ambient temperature

• Retraining to procedure for the identified personnel involved in its execution completed 1/29/10
• AAMI Design Controls Training for employees involved in Product Development completed 1/22/10

No further action required
5 Procedures do not ensure that design outputs meet design inputs.
• 102-0083 rev A states that battery shall be designed to have adequate capacity for 300 shocks however no documented verification was performed

• Protocols have been approved and testing begun

o (b)(4) completed; no failures; report pending

o (b)(4) and rechargeable still in process of testing

Testing to updated specifications in process for all batteries

 

Estimated completion of all test protocols and reports by 4/30/10

6 Adverse event reporting
exceeded 30 days after the date
the firm became aware

• Utilize CAPA process to develop and implement actions to prevent recurrence of this nonconformity
• Retraining of personnel involved in MDR filing activities
• Implementation of (b)(4) Complaint Handling Module to provide:

o clarity in tracking of events requiring adverse reporting
o automated notification when reporting deadlines approaching

Implementation of (b)(4) Complaint Module by (b)(4)

 

Retraining of personnel by
3/31/09