BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1901705 · Received November 12, 2010

    Report

    Report Number
    3002158293-2010-01202
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 20, 2010
    Report Date
    November 10, 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: DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD CHARGE) WAS CONFIRMED. UPON EVAL, IT WAS FOUND THAT THE BATTERY HAD DEFECTIVE CELLS. ONE OR MORE OF THE CELLS HAD RESIDUE/CORROSION ON THEM. THE SOURCE OF THE RESIDUE/CORROSION HAS NOT BEEN POSITIVELY IDENTIFIED BUT IS LIKELY ELECTROLYTE FROM A LEAKING CELL. THE ROOT CAUSE OF THE LEAKING CELL WAS NOT POSITIVELY IDENTIFIED. 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) OLD MALE PT CALLED INTO ZOLL CUSTOMER SUPPORT TO REPORT THAT ONE OF HIS BATTERIES WAS NOT HOLDING A CHARGE. SUPPORT ISSUED THE PT A REPLACEMENT BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR