BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2240950 · Received August 9, 2011

    Report

    Report Number
    3008642652-2011-00399
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    April 3, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD A CHARGE) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY WOULD NOT CHARGE IN THE BATTERY CHARGER NOR POWER UP A MONITOR. LIQUID CONTAMINATION WAS DISCOVERED IN THE BATTERY PACK. THE ROOT CAUSE OF THE LIQUID CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF LIQUID INGRESS DUE TO BATTERY SUBMERSION IN LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK. DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD A CHARGE) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY CHARGER WOULD NOT POWER UP. LIQUID CONTAMINATION WAS DISCOVERED IN THE BATTERY CHARGER. THE ROOT CAUSE OF THE LIQUID CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT THE CONTAMINATED BATTERY (SN (B)(4)) BEING PLACED IN THE CHARGER, THUS SHORTING THE BATTERY CONNECTOR IN THE CHARGER. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERIES WOULD NOT HOLD A CHARGE. THE PATIENT WAS ISSUED TWO REPLACEMENT BATTERY PACKS AND 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 58 YR