BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1864963 · Received October 5, 2010

    Report

    Report Number
    3002158293-2010-01010
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 2, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: BATTERY PACK (B)(4) HAS BEEN EVALUATED. THE REPORTED PROBLEM (BATTERY IS UNABLE TO HOLD A CHARGE) HAS BEEN CONFIRMED. THE BATTERY WAS ALSO FOUND TO HAVE A BENT BATTERY CONTACT (PIN 6) IN THE BATTERY INTERFACE CONNECTOR, NOT ALLOWING THE BATTERY TO MAKE A PROPER CONNECTION WITH THE CHARGER. THE ROOT CAUSE OF THE BENT CONTACT CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY A MISALIGNMENT WITH THE BATTERY CONNECTOR WHILE THE BATTERY WAS BEING FORCED INTO THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    THE DAUGHTER OF A (B)(6) OLD MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF THE PT'S BATTERIES IS UNABLE TO CHARGE. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR