BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1250532 · Received November 14, 2008

    Report

    Report Number
    3002158293-2008-00607
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    August 1, 2008
    Report Date
    November 14, 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

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE PROBLEM WAS CONFIRMED. UPON FURTHER INSPECTION, THE ELECTRODE BELT HAD PINS THAT WERE BENT INSIDE THE CONNECTOR. 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. THE ELECTRODE BELT WAS RETESTED AND THEN RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE BENT PINS. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HE HAD BLUE GEL LEAKING DOWN HIS BACK. HE STATED THAT THERE WERE NO ALARMS. HE STATED THAT HE WAS STANDING IN HIS KITCHEN AND TURNED TO LOOK AT SOMETHING WHEN BOTH HE AND HIS BROTHER HEARD A "RIPPING SOUND LIKE VELCRO COMING APART." SUPPORT ASKED FOR A DOWNLOAD WHICH DID NOT SHOW ANY GEL RELEASE FLAGS. SUPPORT SENT THE PT A REPLACEMENT ELECTRODE BELT.

    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 35 YR