BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1250039 · Received November 14, 2008

    Report

    Report Number
    3002158293-2008-00603
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 8, 2008
    Report Date
    November 14, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR HAS BEEN COMPLETED. THE CAUSE OF THE MONITOR NOT POWERING UP WAS FAULTY RESISTOR, R45, IN THE CHARGE CIRCUIT FOR THE HV CAPACITORS ON THE DEFIBRILLATOR PCA WITHIN THE MONITOR. R45 WAS BURNT UP. THIS RESISTOR IS 2.2 OHM 1/4 WATT METAL ELECTRODE FACE BONDED (MELF) SURFACE MOUNT RESISTOR IN A 1206 PACKAGE. R45 EXISTS IN THE CIRCUIT THAT CONNECTS THE HV_CAP_NEG WITH OUT_GND WHEN THE CHARGE RELAY IS ENERGIZED. THE VOLTAGE THAT WAS SUPPOSED TO BE DISSIPATED BY THIS RESISTOR WAS THEN DELIVERED TO OTHER PARTS OF THE MONITOR. THE RELAY CONTACTS WERE LATCHED TOGETHER. THERE WERE MULTIPLE PARTS BURNT ON THE DEFIBRILLATOR BOARD. THE ROOT CAUSE OF THE DEFECTIVE R45 CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY A RANDOM COMPONENT FAILURE. THIS IS AN UNUSUAL EVENT. NO ADVERSE EVENT RESULTED FROM THE R45 FAILURE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE MONITOR EXPLODED. THE PT HUNG UP BEFORE SUPPORT COULD GET ANY MORE DETAILS. SUPPORT CONTACTED THE PT'S SON WHO STATED THAT AFTER THE PT CHANGED HIS BATTERY PACK, THEY HEARD A LOUD POP. THE SON STATED THAT THE DEVICE WOULD NOT POWER UP WITH EITHER BATTERY PACK. SUPPORT SENT A LIFECOR TERRITORY MANAGER (TM) TO THE PT TO REPLACE THE MONITOR.

    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 68 YR