BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1920884 · Received December 7, 2010

    Report

    Report Number
    3002158293-2010-01299
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    September 25, 2010
    Report Date
    December 4, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: BATTERY PACK (B)(4): 11/2008. BATTERY PACK (B)(4): 01/2008. DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF BATTERIES (B)(4) AND (B)(4) HAVE BEEN COMPLETED. THE REPORTED PROBLEM (BATTERIES ARE UNABLE TO POWER ON THE MONITOR) HAS BEEN CONFIRMED. UPON EVAL, BATTERY PACK (B)(4) WAS FOUND TO HAVE A BENT PIN IN THE CONNECTOR. PIN 5 WAS BENT AND PREVENTED THE BATTERY FROM SUCCESSFULLY COMMUNICATING WITH THE CHARGE/MONITOR. THE ROOT CAUSE OF THE BENT PIN CANNOT BE POSITIVELY IDENTIFIED BUT MAY HAVE RESULTED FROM BUMPING OR DROPPING THE PACK ON A HARD SURFACE OR MISALIGNMENT ISSUE WHEN THE BATTERY PACK WAS BEING INSERTED INTO THE MONITOR. UPON EVAL OF BATTERY PACK (B)(4), DEFECTIVE CELLS WERE DISCOVERED WITHIN THE BATTERY PACK. ONE OR MORE OF THE CELLS HAD RESIDUE/CORROSION ON THEM. THE SOURCE OF THE RESIDUE/CORROSION HAS NOT BEEN POSITIVELY IDENTIFIED BUT IS LIKELY ELECTROLYTE FROM A LEAKING CELL. THE ROOT CAUSE OF THE LEAKING CELL WAS NOT POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERIES. THE PT RECEIVED TWO REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    THE PT SVC REP (PSR) ASSISTING A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT NEITHER OF THE PT'S BATTERY PACKS WOULD POWER ON THE MONITOR. SUPPORT ISSUED THE PT A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR