BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1912996 · Received November 18, 2010

    Report

    Report Number
    3002158293-2010-01230
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Removal / Correction Number
    3002158293-10/08/2010-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM HAS BEEN CONFIRMED. THE CAUSE OF THE RESPONSE BUTTONS NOT POWERING ON THE SYS WAS DUE TO A DEFECTIVE FRONT RESPONSE BUTTON. THE CAUSE OF THE DEFECTIVE RESPONSE BUTTON WAS A CRACKED CONDUCTOR ON THE FLEX CIRCUIT TAIL. THE ROOT CAUSE APPEARS TO BE AN ASSEMBLY ERROR. THE FLEX CIRCUIT WAS INADVERTENTLY CREASED BENEATH THE DISPLAY ENCLOSURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL LIFECOR CUSTOMER SUPPORT SVC CONTACTED A (B)(6) MALE PT TO REQUEST THE RETURN OF HIS MONITOR DUE TO THE RECALL RELATED TO RESPONSE BUTTON FAILURES. THE PT WAS PROVIDED WITH A REPLACEMENT MONITOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR