BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 5934897 · Received September 7, 2016

    Report

    Report Number
    3010617000-2016-00642
    Event Type
    Malfunction
    Date Received
    September 7, 2016
    Date of Event
    July 8, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111065009
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N: (B)(4)) WAS RETURNED TO AZM FOR INVESTIGATION ON AN UNSPECIFIED DATE. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N: (B)(4) WAS EVALUATED BY AZM. VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE FOUND. DURING FUNCTIONAL TESTING, THE USER ADVISORY (UA) 08 (MOTOR CONTROLLER FAULT DETECTED) ERROR MESSAGE WAS OBSERVED. IN SUMMARY, THE CUSTOMER'S PRIMARY COMPLAINT WAS CONFIRMED. THE AUTOPULSE PLATFORM IS A REUSABLE DEVICE AND WAS MANUFACTURED ON 2011. THIS TYPE OF ISSUE IS CHARACTERISTIC OF NORMAL WEAR FOR THE LIFE OF THE DEVICE. ALTHOUGH THE ROOT CAUSE COULD NOT BE DETERMINED, A POSSIBLE CAUSE IS A MOTOR BOARD FAILURE.

    Description of Event or Problem · 1

    DURING A SHIFT CHECK, IT WAS REPORTED THAT THE AUTOPULSE PLATFORM (S/N: (B)(4)) DISPLAYED A USER ADVISORY (UA) 08 (MOTOR CONTROLLER FAULT DETECTED) ERROR MESSAGE. DESPITE RESTARTING THE DEVICE, THE UA08 MESSAGE DID NOT CLEAR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584858 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100 00849111065009

    Patients

    Seq Age Sex Outcome Treatment
    1