BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1172627 · Received September 19, 2008

    Report

    Report Number
    3002158293-2008-00461
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 18, 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 BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE BAD BATTERY LED WAS A BLOWN FUSE WITHIN THE BATTERY PACK. THE ROOT CAUSE OF THE BLOWN FUSE IS NOT KNOWN, BUT WAS LIKELY RANDOM COMPONENT FAILURE. THE BLOWN FUSE WAS REPLACED. THE BATTERY PACK WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE FAULTY BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF HIS BATTERY PACKS WOULD NOT START UP THE MONITOR. HE STATED THAT WHEN THIS BATTERY PACK WAS PLACED IN THE BATTERY CHARGER THE RED BLINKING BAD BATTERY LED ILLUMINATED. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT TO REPLACE THE 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 77 YR