BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3073079 · Received April 8, 2013

    Report

    Report Number
    3008642652-2013-00904
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 1, 2013
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 107, WON'T POWER UP) WAS CONFIRMED. UPON INVESTIGATION EXTENSIVE CONTAMINATION WAS DISCOVERED INSIDE OF THE MONITOR, WHICH CAUSED THE REPORTED ABNORMAL SHUTDOWNS. THE ROOT CAUSE FOR THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED MONITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER MONITOR WAS DISPLAYING A SERVICE CODE 107 AND THEN WOULD NOT POWER UP. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144435 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR