BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121027 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00375
    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 Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: BATTERY CHARGER, BATTERY PACK. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF BATTERY CHARGER, BATTERY PACKS HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CHARGER WAS DEFECTIVE WHEN EVALUATED. THE POWER CORD CONNECTOR WAS DEFECTIVE. THE POWER CONNECTOR WAS LOOSE AT THE BASE. THE CONNECTOR WAS REPAIRED. THE BATTERY CHARGE WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DEFECTIVE POWER CORD CONNECTOR IS UNKNOWN BUT IS LIKELY DUE TO MISMATCH OF THE POWER CORD CONNECTOR WITH THE BASE STATION. BOTH BATTERY PACKS WERE FULLY FUNCTIONAL. THERE WERE RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY CHARGER. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER AND TWO REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER IS NOT CHARGING HIS BATTERY PACKS. HE STATED THAT THE LIGHT ON THE BRICK LIGHTS UP, BUT THERE ARE NOT ANY LIGHTS THAT COME ON THE CHARGER WHEN HE PLACES A BATTERY PACK INTO THE CHARGER. HE STATED THAT HE HAD CHECKED THE CONNECTION AT THE BACK OF THE BASE. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO EXCHANGE THE BATTERY CHARGER AND BOTH BATTERY PACKS.

    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 48 YR