BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1952447 · Received January 4, 2011

    Report

    Report Number
    3002158293-2010-01385
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 24, 2010
    Report Date
    December 31, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY PACK WAS FOUND TO HAVE A BENT PIN IN THE CONNECTOR. PIN 6 WAS BENT AND PREVENTED THE BATTERY FROM SUCCESSFULLY COMMUNICATING WITH THE CHARGER/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. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    ZOLL LIFECOR CUSTOMER SUPPORT REVIEWED THE DOWNLOAD OF A (B)(6) MALE PT, WHICH REVEALED SEVERAL BATTERY CHARGER FAULTS. 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 58 YR