BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEMS

    MDR report key: 1172629 · Received September 19, 2008

    Report

    Report Number
    3002158293-2008-00459
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 18, 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 - MONITOR - 2006; BATTERY PACKS - 2008; BATTERY CHARGER - 2006. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF MONITOR, BATTERY PACKS, AND BATTERY CHARGER HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS REPRODUCED. THE CHARGER WAS DEFECTIVE WHEN EVALUATED. THE CONNECTOR AT THE BASE OF THE BATTERY CHARGER WOULD NOT STAY IN THE BATTERY CHARGER BASE. THE CONNECTOR WAS REPLACED. THE BATTERY CHARGER WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK IS UNKNOWN BUT IS LIKELY MISMATING OF THE CONNECTORS. BATTERY PACK HAD DEFECTIVE CELLS. THE ROOT CAUSE OF THE DEFECTIVE CELLS WAS BECAUSE THE PATIENT WAS NOT FULLY CHARGING THE BATTERY PACK. THE BATTERY PACK WAS PROBABLY STARTING TO CHARGE, BUT THEN THE BATTERY CHARGER POWER CONNECTOR WOULD COME LOOSE AND THE BATTERY PACK WOULD STOP CHARGING. IT WAS REPAIRED, RETESTED AND RESTOCKED. THE OTHER BATTERY PACK AND THE MONITOR WERE FULLY FUNCTIONAL. THEY WERE RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY CHARGER AND BATTERY PACK. THE PATIENT RECEIVED REPLACEMENT BATTERY CHARGER, MONITOR AND BATTERY PACKS.

    Description of Event or Problem · 1

    THE DAUGHTER OF A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF HER MOTHER'S BATTERY PACK WAS NOT CHARGING. SHE ALSO STATED THAT WHEN THIS BATTERY PACK WAS PLACED INTO THE BATTERY CHARGER THE RED LED FLASHES. SHE CONTINUED TO STATE THAT THE SYSTEM DOES NOT EVEN POWER UP WHEN THEY PLACE THIS BATTERY PACK INTO THE MONITOR. SUPPORT ASKED THE PATIENT'S DAUGHTER TO DOWNLOAD TO EVALUATE WHICH EQUIPMENT NEEDS TO BE REPLACED. THE PATIENT'S DAUGHTER CALLED BACK AND STATED THAT NOW NEITHER BATTERY PACK IS POWERING THE MONITOR. SUPPORT SENT THE PATIENT A REPLACEMENT MONITOR, BATTERY PACKS AND BATTERY CHARGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR