BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3033152 · Received March 1, 2013

    Report

    Report Number
    3008642652-2013-00545
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 20, 2013
    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/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT CHARGE BATTERIES) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS CONTAMINATION ON THE BATTERY BOARD INSIDE THE CHARGER/MODEM. IN ADDITION, COMPONENT U13 (8-BIT CMOS FLASH MICRO-CONTROLLER) COMPONENT WAS SHORTED. THE CAUSE OF INABILITY TO CHARGE THE BATTERIES IS THE CONTAMINATION AND THE SHORTED U13. THE CAUSE OF THE SHORTED U13 IS LIKELY THE CONTAMINATION. THE ROOT CASE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS OF AN UNK CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE BATTERY CHARGER WOULD NOT CHARGE THE BATTERIES. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90273 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR