BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2800065 · Received October 12, 2012

    Report

    Report Number
    3008642652-2012-02698
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 26, 2012
    Report Date
    October 5, 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 CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER POWER CONNECTOR PROBLEM) HAS BEEN CONFIRMED. UPON EVALUATION, THE POWER SUPPLY UNIT WAS DEFECTIVE. THE CAUSE OF THE INABILITY TO CHARGE THE BATTERIES IS THE DEFECTIVE POWER SUPPLY UNIT. THE CAUSE OF THE DEFECTIVE POWER UNIT IS A DAMAGED CONNECTOR. THE CONNECTOR ON THE CHARGER WAS WORN OUT AND ABLE TO BE REMOVED FROM BATTERY CHARGER. THE ROOT CAUSE OF THE DAMAGED CONNECTOR WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED POWER UNIT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PATIENT'S BATTERY CHARGER'S POWER CONNECTOR WAS DAMAGED. THE PATIENT 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 43 YR