BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2881163 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03002
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT CHARGE BATTERIES) HAS BEEN CONFIRMED. UPON RECEIPT, THE CHARGER WOULD NOT CHARGE A BATTERY. THE CAUSE OF THE INABILITY TO CHARGE IS A DEFECTIVE POWER UNIT. THE CAUSE OF THE DEFECTIVE POWER UNIT IS DISCONNECTED PINS IN THE CONNECTOR. THE ROOT CAUSE FOR THE DISCONNECTED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER UNIT. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WAS NOT CHARGING HIS BATTERY PACKS. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    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 61 YR