BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3060681 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00800
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING. UPON EVAL, THE COMPUTER / ANALOG (CA) AND DEFIBRILLATOR BOARDS WERE BOWED WHICH CAUSED PHYSICAL DAMAGE TO CAPACITOR C220 AND Y500. IN ADDITION, THE U500 COMPONENT (DSP) WAS CRACKED AND THE LEADS OF HIGH-VOLTAGE CAPACITORS C20 AND C21 WERE DETACHED. THE CAUSE OF THE TEST FAILURE IS THE EXTENSIVE DAMAGE TO THE CA AND DEFIBRILLATOR BOARDS. THE CAUSE OF THE DAMAGE TO THE BOARDS IS MECHANICAL SHOCK FROM PHYSICAL IMPACT, AS EVIDENCED BY PHYSICAL DAMAGE TO THE MONITOR CASE. (B)(4). NO ADVERSE EVENT RESULTED FROM THE BROKEN LEAD ON C22. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A TERRITORY MGR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT'S DOCTOR INDICATED THAT THE PT'S MONITOR WAS BROKEN. DURING SERVICING OF THE PT'S MONITOR, A REPORTABLE PROBLEM WAS DISCOVERED. THE MONITOR FAILED INCOMING TESTING. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131066 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR