BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823645 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01345
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTER PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED BATTERY CASING) HAS BEEN CONFIRMED. UPON RECEIPT OF THE BATTERY CASING WAS BURNT AND THE BATTERY PACK WAS SHORTED. THE ROOT CAUSE FOR THE BURNT CASE AND SHORTED BATTERY PACK CANNOT BE POSITIVELY DETERMINED BUT MAY HAVE BEEN CAUSED BY INGRESS OF AN UNKNOWN CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT'S DAUGHTER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY WAS MELTED AND STUCK IN THE CHARGER. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261660 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR