BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1214122 · Received October 24, 2008

    Report

    Report Number
    3002158293-2008-00555
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MONITOR AND BATTERY PACKS - 2008. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR, BATTERY PACKS, HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE MONITOR WAS FOUND TO HAVE A DEFECTIVE BATTERY CONNECTOR. THE CONNECTOR PINS WERE BENT. THE CONNECTOR WAS REPAIRED. THE MONITOR WAS RETESTED AND THEN RESTOCKED. THE ROOT CAUSE OF THE BENT PINS IS UNKNOWN, BUT IS LIKELY DUE TO A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. BOTH BATTERY PACKS HAD DAMAGED CONNECTORS. THE ROOT CAUSE WAS SLAMMING THE BATTERY PACKS INTO THE MONITOR. THE BATTERY PACK CONNECTOR WERE REPLACED. THE BATTERY PACKS WERE RETESTED AND RESTOCKED. THE DAMAGED CONNECTORS ON THE MONITOR AND BATTERY PACKS WERE REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED MONITOR OR BATTERY PACKS. THE PATIENT RECEIVED A REPLACEMENT MONITOR AND BATTERY PACKS.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT BOTH BATTERY PACKS WILL NOT FIT INTO THE MONITOR. SUPPORT SENT THE PATIENT A REPLACEMENT MONITOR AND BATTERY PACKS.

    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 63 YR