BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1121048 · Received August 14, 2008

    Report

    Report Number
    3002158293-2008-00376
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 7, 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 MANUFACTURE DATE: BATTERY CHARGER; BATTERY PACK - 01/2008 AND OTHER BATTERY PACK - 01/2008. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF BATTERY CHARGER, AND 2 BATTERY PACKS HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CAUSE OF THE BATTERY PACKS NOT CHARGING COMPLETELY WAS CORROSION ON THE CIRCUIT BOARD OF THE BATTERY CHARGER WHERE THE BATTERY CONNECTOR ATTACHES. MULTIPLE SOLDER JOINTS INSIDE THE CHARGER HAD CORROSION AND RUST ON THEM. THE ROOT CAUSE OF THE CORRODED CIRCUIT BOARD WAS PROBABLY LIQUID SPILLAGE INTO THE BATTERY WELL AREA OF THE CHARGER. THE BATTERY CHARGER WAS SCRAPPED. ONE BATTERY PACK WAS FOUND TO HAVE CORROSION ON THE CONNECTOR. IT ALSO HAD BENT CONNECTOR PINS. THE ROOT CAUSE OF THE CORROSION WAS DUE TO THE CONTAMINATED BATTERY PACK. THE BATTERY WAS REPAIRED, RETESTED AND RESTOCKED. THE OTHER BATTERY PACK WAS FOUND TO HAVE CORROSION ON THE CONNECTOR. THE ROOT CAUSE OF THE CORROSION WAS DUE TO THE CONTAMINATED BATTERY PACK. IT WAS FULL OF WATER. IT WAS SCRAPPED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER OR BATTERY PACKS. THE PATIENT RECEIVED REPLACEMENT BATTERY PACKS AND CHARGER.

    Description of Event or Problem · 1

    A MALE PATIENT LEFT A NON-URGENT VOICE MAIL REPORTING THAT HE WAS HAVING A PROBLEM WITH HIS BATTERY PACK. LIFECOR CUSTOMER SUPPORT CONTACTED THE PATIENT WHO STATED THAT ONE OF HIS BATTERY PACKS WAS DEAD. HE STATED THAT IT WOULD NOT CHARGE AT ALL. HE SAID THAT IT DISPLAYED THE FLASHING RED "BATTERY FAULT" LED WHEN THE BATTERY PACK WAS INSERTED INTO THE CHARGER. THE PATIENT WAS AT WORK AND WAS UNABLE TO PERFORM A DOWNLOAD. SUPPORT SENT THE PATIENT A REPLACEMENT BATTERY PACK. SUPPORT NOTICED A PATIENT DOWNLOAD LATER IN THE DAY THAT REVEALED "BATTERY PACK FAULT" AND "BATTERY RUNTIME EXPIRED" FLAGS. THESE FAULTS APPEAR TO BE ON ANOTHER BATTERY PACK. THE PATIENT CALLED SUPPORT, AND STATED THAT THE CHARGER WAS NOT WORKING. HE SAID THAT THE NEW BATTERY PACK DID NOT SOLVE THE PROBLEM. HE STATED THAT WHEN HE PLACED THE NEW BATTERY PACK INTO THE CHARGER, THE LIGHTS WOULD ALL COME ON AND THEN ALL SHUT OFF. SUPPORT SENT THE PATIENT A REPLACEMENT BATTERY PACK AND BATTERY CHARGER.

    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 54 YR