BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2081742 · Received April 11, 2011

    Report

    Report Number
    3002158293-2011-00396
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    February 28, 2011
    Report Date
    April 8, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD CHARGE) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY WAS FOUND TO HAVE A POORLY SOLDERED THERMISTOR. THE THERMISTOR WAS NOT SOLDERED CORRECTLY TO THE PAD ON THE BATTERY BOARD PCA. THIS PREVENTED THE BATTERY FROM PROPERLY CHARGING ON THE BATTERY CHARGER. THE ROOT CAUSE OF THE POOR SOLDER CONNECTION CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY AN ASSEMBLY ERROR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER CHARGER WOULD NOT RECOGNIZE HER BATTERIES. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER AND BATTERY PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR