BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121045 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00367
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    June 9, 2008
    Report Date
    August 13, 2008
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE BATTERY NOT CHARGING WAS DUE TO A BROKEN BLACK WIRE ON THE CELLS. THE BLACK WIRE CONNECTS THE CELLS TO THE BOARD. THE BLACK WIRE HAD A SOLDER DOME ON THE BOARD SIDE. THE SOLDER DOME CAUSED THE WIRE TO BE PUNCTURED. THE WIRE THEN SHORTED TO THE GROUND PAD. THE ROOT CAUSE OF THE BROKEN WIRE WAS A MANUFACTURING ASSEMBLY ERROR OF TOO MUCH SOLDER ON THIS LEAD. THE WIRE WAS REPLACED. THE BATTERY PACK WAS RETESTED AND RESTOCKED. THE ASSEMBLER WHO CREATED THIS BATTERY PACK IS NO LONGER WITH LIFECOR. NO ADVERSE EVENT RESULTED FROM THE FAULTY BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    THE SISTER OF A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF THE PATIENT'S BATTERY PACKS WAS NOT CHARGING CORRECTLY. THE MOST RECENT DOWNLOAD FROM THIS PATIENT REVEALED "BATTERY CHARGER FAULT" FLAGS. SUPPORT SENT THE PATIENT 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK