BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3885111 · Received June 19, 2014

    Report

    Report Number
    3003793491-2014-00293
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO ZOLL JAPAN FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS NO VISIBLE OR PHYSICAL DAMAGE TO THE PLATFORM. A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED AT ZOLL (B)(4) AND THE REPORTED COMPLAINT WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION) OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE WAS REPRODUCED. IN ADDITION, THE UA16 FAULT WAS OBSERVED ON THE DISPLAY. IT WAS OBSERVED THAT THE BRAKE GAP WAS OUT OF SPECIFICATION. THE BRAKE GAP WAS ADJUSTED AND THE PLATFORM PASSED TESTING. BASED ON THE INVESTIGATION, NO PARTS WERE IDENTIFIED FOR REPLACEMENT. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE ARCHIVE REVIEW AND DURING FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO THE BRAKE GAP BEING OUT OF SPECIFICATION. UPON ADJUSTING THE BRAKE GAP WITHIN SPECIFICATION, THE PLATFORM WAS RE-EVALUATED THROUGH FUNCTIONAL TESTING AND THE PLATFORM PASSED ALL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS INITIALLY RECEIVED BY ZOLL (B)(4). ZOLL (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S REPORTED COMPLAINT. IN ADDITION ZOLL (B)(4) ALSO OBSERVED A USER ADVISORY 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ON THE AUTOPULSE® DISPLAY. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A DEVICE CHECK WHEN THE START/CONTINUE BUTTON WAS PRESSED, THE DRIVESHAFT WOULD NOT ROTATE TO ALLOW THE LIFEBAND® TO PERFORM TAKE-UP. EVEN THOUGH COMPLAINANT ATTEMPTED TO REINSTALL AND PULL THE LIFEBAND® UP COMPLETELY, THE ISSUE STILL PERSISTED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360678 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1