BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1202422 · Received October 17, 2008

    Report

    Report Number
    3002158293-2008-00537
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: MONITOR - 02/2008. BATTERY PACK - 02/2008. THE SECOND BATTERY PACK - 02/2008. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR, AND THE TWO 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 WERE FULL FUNCTIONAL. THE BATTERY PACKS WERE RETESTED AND RESTOCKED. THE DAMAGED CONNECTOR ON THE MONITOR WAS REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED MONITOR. THE PSR RECEIVED A REPLACEMENT MONITOR AND BATTERY PACKS.

    Description of Event or Problem · 1

    A LIFECOR PATIENT SERVICES REPRESENTATIVE (PSR) CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT NEITHER BATTERY PACK WOULD FIT INTO THE MONITOR. SUPPORT SENT THE PSR 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 NA