BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3771723 · Received April 24, 2014

    Report

    Report Number
    3003793491-2014-00211
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT ALSO REPORTED THAT WHEN THE CREW ATTEMPTED TO USE THIS DEVICE ON A MANNEQUIN BACK AT THE STATION, THEY DID NOT EXPERIENCE ANY PROBLEMS. THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE OBSERVED. THE REPORTED ISSUE COULD NOT BE DUPLICATED DURING FUNCTIONAL TESTING. THE PLATFORM WAS RUN WITH A TEST MANIKIN AS WELL AS A LARGE RESUSCITATION TEST FIXTURE (EQUIVALENT TO A 250 POUND PATIENT) AND NO PROBLEMS WERE ENCOUNTERED. THE MOTOR BRAKE GAP WAS ALSO MEASURED AND FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE ARCHIVE WAS PERFORMED AND MULTIPLE SESSIONS WERE OBSERVED DURING WHICH THE FOLLOWING FAULTS WERE OBSERVED ON THE REPORTED EVENT DATE OF (B)(4) 2014: USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE), UA 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION), AND UA 12 (LIFE BAND NOT PRESENT). THE REPORTED COMPLAINT WAS CONFIRMED BASED ON REVIEW OF THE ARCHIVE. THE DATA INDICATES UA 7 AND UA 17 FAULTS OCCURRING AND THE CAUSE OF BOTH FAULTS TO BE PATIENT MOVEMENT OR REALIGNMENT DURING OPERATION. THE DATA ALSO SHOWS THAT THE PLATFORM WAS POWERED ON AND OFF MULTIPLE TIMES, HOWEVER, IT CANNOT BE DETERMINED WHETHER THE DEVICE POWERED OFF BY ITSELF OR IF THE POWER BUTTON WAS PRESSED. IT SHOULD BE NOTED THAT INITIAL EVENT INFORMATION PROVIDED BY THE CUSTOMER ALSO INDICATED THAT THEY BELIEVE THAT THE REPORTED ISSUE WAS DUE TO REALIGNMENT AND/OR MOVEMENT OF THE PATIENT DURING OPERATION. THE UA 12 OBSERVED IN THE ARCHIVE APPEARS UNRELATED TO THE REPORTED EVENT AND LIKELY DUE TO THE CUSTOMER REMOVING OR OPENING THE LIFEBAND. BASED ON THE INVESTIGATION, NO PART(S) WERE IDENTIFIED FOR REPLACEMENT. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING ARCHIVE REVIEW AND FOUND TO BE DUE TO PATIENT MOVEMENT DURING OPERATION OF THE PLATFORM. FOLLOWING SERVICE, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT AFTER USE ON A PATIENT, THE AUTOPULSE ARCHIVE WAS DOWNLOADED. REVIEW OF THE ARCHIVE INDICATED THAT THE AUTOPULSE PLATFORM TURNED ON/OFF MULTIPLE TIMES, HOWEVER, THE POWER BUTTON WAS NEVER PRESSED. THE ARCHIVE ALSO REVEALED THAT THE UNIT TURNED OFF FOR A PERIOD OF 5 MINUTES. DURING THIS EVENT, THE CREW HAD TO RE-ALIGN THE PATIENT A FEW TIMES, WHICH IS CAPTURED IN THE ARCHIVE AS THE UNIT TURNING OFF/ON. COMPLAINANT ALLEGED THAT THE CREW NEVER NOTICED THE UNIT TURNING OFF/ON OR STOPPING COMPRESSIONS DURING THIS EVENT. COMPLAINANT ALSO INDICATED THAT THE PATIENT WAS ALREADY IN RIGOR MORTIS AND BELIEVES THAT THE PATIENT'S WEIGHT DISTRIBUTION MAY HAVE CONTRIBUTED TO THIS. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249985 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR