BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1082858 · Received July 25, 2008

    Report

    Report Number
    3002158293-2008-00331
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR HAS 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. THE DAMAGED CONNECTOR ON THE MONITOR WAS REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED MONITOR. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS WITH IT.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF MONITOR, WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT MONITOR HAD A SMASHED BATTERY CONNECTOR, AND WOULD NOT POWER UP. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY PROBLEMS WITH IT.

    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