BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2062997 · Received March 16, 2011

    Report

    Report Number
    3002158293-2011-00321
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP/BURNING SMELL) HAS BEEN CONFIRMED. 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. 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 INCLUDING (R22, R30, C10 AND C11). ADDITIONALLY, COMPONENTS OF THE COMPUTER ANALOG BOARD WERE AFFECTED BY THIS FAILURE (COMPONENTS U204 AND U205). 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 DEFECTIVE RESISTOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR WAS NOT WORKING AND THERE WAS A BURNING SMELL COMING FROM THE MONITOR. THE PT WAS ISSUED A REPLACEMENT 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 62 YR