BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3653343 · Received January 24, 2014

    Report

    Report Number
    3008642652-2014-00301
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 24, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING FUNCTIONAL TESTING. UPON INVESTIGATION IT WAS DISCOVERED THAT RESISTOR R781 ON THE MONITOR CA BOARD WAS OPEN, CAUSING A LACK OF DRIVEN GROUND CIRCUITY. THE CAUSE FOR THE TEST FAILURES IS THE LACK OF DRIVEN GROUND. THE CAUSE FOR THE LACK OF DRIVEN GROUND IS THE OPEN R781 RESISTOR. THE ROOT CAUSE OF THE OPEN R781 IS UNABLE TO BE POSITIVELY IDENTIFIED, BUT THIS TYPE OF FAILURE IS CONSISTENT WITH EMERGENCY EXTERNAL DEFIBRILLATION WHILE THE PT IS WEARING THE DEVICE. LABELING ON THE PT GARMENT INDICATES THAT THE ELECTRODE BELT SHOULD BE DISCONNECTED FROM THE MONITOR BEFORE ADMINISTERING EXTERNAL DEFIBRILLATION. THERE IS NO EVIDENCE THAT THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PT DEATH. EXG RECORDINGS AND FLAG FILES FORM THE DEVICE SHOW THAT THE EQUIPMENT WAS FULLY FUNCTIONAL DURING PT USE PRIOR TO THE NON-TREATABLE RHYTHMS. A REPLACEMENT ELECTRODE BELT AND MONITOR WERE NOT REQUIRED.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE LIFEVEST DEVICE A REPORTED PROBLEM WAS DETECTED. MONITOR SN (B)(4) WAS UNABLE TO COMMUNICATE WITH THE ECGS OF A TEST ELECTRODE BELT AND FAILED INCOMING FUNCTIONAL TESTING. THE EQUIPMENT WAS LAST ASSOCIATED WITH A (B)(6) MALE PT WHO EXPERIENCED NON-TREATABLE RHYTHMS (BRADYCARDIA AND ASYSTOLE) AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2013. THE DEVICE PROPERLY DETECTED BRADYCARDIA AND ASYSTOLE. THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PT DEATH AS THE DEVICE'S ECG RECORDINGS AND FLAG FILES SHOW THAT THE EQUIPMENT WAS FULLY FUNCTIONAL DURING PT USE PRIOR TO DETECTION OF THE NON-TREATABLE RHYTHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55832 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR