BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2904558 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03170
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 20, 2012
    Report Date
    November 29, 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 EVALUATION, THERE WAS CONTAMINATION ON THE PCA BOARD INSIDE THE BATTERY CHARGER. THE CAUSE OF THE INABILITY TO CHARGE THE BATTERIES IS THE CONTAMINATION ON THE PCA BOARD. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS OF AN UNKNOWN CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED BATTERY CHARGER. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT'S SON CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER WAS NOT CHARGING THE PATIENT'S BATTERIES. THE PATIENT WAS ISSUED 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 89 YR