BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3823577 · Received May 1, 2014

    Report

    Report Number
    3008642652-2014-01352
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM STRAIN RELIEF, THE TRUNK TO DN CABLE WAS PULLED FROM THE STRAIN RELIEF DAMAGING CONNECTOR J702 ON THE DN AND THE ECG-B TO DN CABLE WAS PULLED FROM THE STRAIN RELIEF DAMAGING CONNECTOR J703 ON THE DN. THE ROOT CAUSE OF THE DAMAGED CABLES COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE APPLIED WHEN REMOVING THE DEVICE FROM THE PATIENT. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING TESTING. UPON EVALUATION, THE R781 RESISTOR WAS OPEN AND Q17 WAS SHORTED. THE CAUSE OF THE OPEN R781 AND SHORTED Q17 IS LIKELY THE EXTERNAL DEFIBRILLATION. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. A REVIEW OF THE PATIENT'S FLAGS SUGGESTS THAT THE DEVICE WAS FULLY FUNCTIONAL DURING USE. DEVICE MANUFACTURE DATE: SN (B)(4), SN (B)(4): 02/01/2013.

    Description of Event or Problem · 1

    DURING INVESTIGATION INTO A (B)(6) PATIENT'S DEVICE, WHICH WAS RETURNED AFTER THE PATIENT HAD PASSED, A REPORTABLE PROBLEM WAS DETECTED. THE (B)(6) DISTRIBUTOR REPORTED THAT THE PATIENT WAS AT THE HOSPITAL AT THE TIME OF THE PASSING AND THAT THE HOSPITAL STAFF EXTERNALLY DEFIBRILLATED THE PATIENT AND REMOVED THE ELECTRODE BELT. THE CAUSE OF DEATH WAS NOT CARDIAC RELATED. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. REVIEW OF THE PATIENT'S FLAGS SUGGESTS THAT THE DEVICE WAS FULLY FUNCTIONAL DURING USE. THE MONITOR FAILED INCOMING TESTING. THE ELECTRODE BELT WAS RECEIVED WITH ALL CABLES PULLED FROM THE DISTRIBUTION NODE. THE PATIENT DID NOT REQUIRE A REPLACEMENT MONITOR AND ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261189 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK