BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2241536 · Received August 9, 2011

    Report

    Report Number
    3008642652-2011-00400
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 29, 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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WILL NOT 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 ONE OF HER BATTERY PACKS WOULD NOT HOLD A CHARGE. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    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 61 YR