BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6125877 · Received November 23, 2016

    Report

    Report Number
    3008642652-2016-08652
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    October 27, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY- MONITOR SN (B)(4) EVALUATION: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING. UPON EVALUATION, THE R781 RESISTOR WAS OPEN ON THE COMPUTER/ANALOG (CA) BOARD. THE CAUSE OF THE INCOMING TEST FAILURE IS THE OPEN RESISTOR. THE ROOT CAUSE OF THE OPEN RESISTOR CANNOT BE POSITIVELY IDENTIFIED, HOWEVER THE FAILURE IS CONSISTENT WITH EXTERNAL DEFIBRILLATION. THERE IS NO INDICATION THAT THE MALFUNCTION CONTRIBUTED TO THE TREATMENT OR THE PATIENT DEATH. ELECTRODE BELT SN (B)(4) EVALUATION: THE ELECTRODE BELT ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 08/01/2014 REUSE, ELECTRODE BELT: SN (B)(4): 11/06/2015 REUSE.

    Additional Manufacturer Narrative · 1

    ELECTRODE BELT SN (B)(4) EVALUATION: THE ELECTRODE BELT ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MONITOR SN (B)(4) EVALUATION: MONITOR EVALUATION IS UNDERWAY. AS RECEIVED THE MONITOR WAS UNABLE TO PASS INCOMING FUNCTIONALITY TESTING. INVESTIGATION IS UNDERWAY AND A SUPPLEMENT WILL BE SENT ONCE MONITOR EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING SERVICING OF MONITOR SN (B)(4) WHICH WAS RETURNED FOR INVESTIGATION INTO A PATIENT'S DEATH, AN UNRELATED REPORTABLE PROBLEM WAS FOUND. THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING. THE DEVICE FAILURE DID NOT CAUSE OR CONTRIBUTE TO THE TREATMENT OR THE PATIENT'S DEATH. THE PATIENT WAS IN A NON-LIFE-SUSTAINING PRIOR TO TREATMENT AS INDICATED BY THE CPR ARTIFACT. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2016 WHILE WEARING THE LIFEVEST. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE EVENT. AT 09:05:50 ON (B)(6) 2016 THE PATIENT'S ECG SHOWED CPR ARTIFACT. TWO TREATMENTS WERE DELIVERED BETWEEN 09:06:37 AND 09:07:17. THE PATIENT'S ECG CONTINUED TO SHOW CPR ARTIFACT. THE ELECTRODE BELT WAS DISCONNECTED AT 10:06:37. THERE IS NO INDICATION THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE DEATH, AS THE PATIENT WAS ALREADY IN A NON-LIFE-SUSTAINING RHYTHM PRIOR TO THE TREATMENT AS INDICATED BY THE CPR ARTIFACT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2016 WHILE WEARING THE LIFEVEST. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE EVENT. AT 09:05:50 ON (B)(6) 2016 THE PATIENT'S ECG SHOWED CPR ARTIFACT. TWO TREATMENTS WERE DELIVERED BETWEEN 09:06:37 AND 09:07:17. THE PATIENT'S ECG CONTINUED TO SHOW CPR ARTIFACT. THE ELECTRODE BELT WAS DISCONNECTED AT 10:06:37. THERE IS NO INDICATION THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE DEATH, AS THE PATIENT WAS ALREADY IN A NON-LIFE-SUSTAINING RHYTHM PRIOR TO THE TREATMENT AS INDICATED BY THE CPR ARTIFACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776149 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death