BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121064 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00360
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 13, 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 ELECTRODE BELT HAS BEEN COMPLETED. UPON FURTHER INSPECTION, THE ELECTRODE BELT HAD PINS THAT WERE BENT INSIDE THE CONNECTOR. THERE WERE NO PINS MISSING. THE ROOT CAUSE OF THE BENT PINS WAS PROBABLY EXCESSIVE FORCE APPLIED TO THE CONNECTOR DURING MATING. THE CONNECTOR WAS FORCED INTO THE MONITOR WHICH DEFEATED THE CONNECTOR KEYING MECHANISM AND ALLOWED THE PINS TO MISALIGN WITH THE MATING SOCKETS. THE DAMAGED ELECTRODE BELT CONNECTOR WAS REPLACED. IT WAS RETESTED AND THEN RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE BENT PINS. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT EXPERIENCE ANY PROBLEMS WITH IT.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF ELECTRODE BELT, WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE CONNECTOR PINS WERE BENT. THE LAST PATIENT TO USE THIS ELECTRODE BELT DID NOT EXPERIENCE ANY PROBLEMS WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA