BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2221447 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00465
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 9, 2011
    Report Date
    August 16, 2011
    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 EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (POWER CONNECTOR PROBLEM) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WOULD NOT POWER UP. THE CAUSE OF THE CHARGER NOT POWERING UP IS A DEFECTIVE POWER UNIT. THE CAUSE OF DEFECTIVE POWER UNIT IS RECESSED PINS IN THE POWER UNIT CONNECTOR. THE ROOT CAUSE OF THE RECESSED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. DEVICE EVAL BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (POWER CONNECTOR PROBLEM) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WOULD NOT POWER UP. THE CAUSE OF THE CHARGER NOT POWERING UP IS A DEFECTIVE POWER UNIT. THE CAUSE OF THE DEFECTIVE POWER UNIT IS RECESSED PINS IN THE POWER UNIT CONNECTOR. THE ROOT CAUSE OF THE RECESSED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER UNITS. DEVICE MANUFACTURE DATE: BATTERY CHARGER SN (B)(4): 06/2009. BATTERY CHARGER SN (B)(4): 04/2007.

    Description of Event or Problem · 1

    A (B)(4) DISTRIBUTOR RETURNED A BATTERY CHARGER THAT HAD A POWER CONNECTOR PROBLEM.

    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 NA