BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1220872 · Received October 29, 2008

    Report

    Report Number
    3002158293-2008-00564
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE BATTERY PACK HAD A DAMAGED BATTERY CONNECTOR. THE ROOT CAUSE OF THE DAMAGE CANNOT BE POSITIVELY IDENTIFIED BUT APPEARS TO BE THE RESULT OF THE BATTERY PACK BEING FORCED INTO A MISALIGNED MONITOR CONNECTOR. THE CONNECTOR WAS REPAIRED. THE BATTERY PACK WAS RETESTED AND THEN RESTOCKED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED BATTERY PACK. THE PSR RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A LIFECOR PATIENT SERVICES REPRESENTATIVE (PSR) CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE WAS SETTING UP A SYSTEM FOR A PATIENT FITTING AND NOTICED THAT ONE OF THE BATTERY PACKS WOULD NOT FIT INTO THE MONITOR. THE PSR NOTICED THAT THERE WERE DAMAGED CONTACTS ON THE BATTERY PACK. THE PSR DIDN'T SEE ANY DAMAGE ON THE MONITOR BATTERY CONNECTOR. SUPPORT SENT THE PSR A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA