BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4201290 · Received October 27, 2014

    Report

    Report Number
    3010617000-2014-00537
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 10/15/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE ENCODER COVER WAS DAMAGED. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED COMPLAINT OF A USER ADVISORY 16 (TIMEOUT MOVING TO TAKE-UP POSITION). THE PHYSICAL DAMAGE APPEARS TO HAVE BEEN NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 4/2009). A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE DATE OF EVENT WAS NOT PROVIDED. HOWEVER, THE ARCHIVE DATA DOES SHOW THAT UA16 FAULT OCCURRED ON (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED COMPLAINT COULD NOT BE REPRODUCED. THE LOAD CELL CHARACTERIZATION TESTING WAS PERFORMED AND INDICATED THAT BOTH LOAD CELL MODULES WERE FUNCTIONING WITHIN SPECIFICATIONS. THE PLATFORM WAS SUBJECTED TO A RUN-IN TEST WITH THE 95% PATIENT TEST FIXTURE WITH GOOD BATTERIES FOR SEVERAL HOURS AND NO FAULTS OR ERRORS WERE OBSERVED. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE FRONT COVER. IN SUMMARY, THE REPORTED COMPLAINT OF UA16 FAULT WAS CONFIRMED BASED ON THE PLATFORM'S ARCHIVE REVIEW BUT COULD NOT REPRODUCED DURING FUNCTIONAL TESTING. THE ROOT CAUSE FOR UA16 FAULT COULD NOT BE DETERMINED. HOWEVER, PER THE AUTOPULSE MAINTENANCE GUIDE, UA16 IS AN INDICATION THAT THERE IS AN OBSTRUCTION BETWEEN THE LIFEBAND AND OBJECT/PATIENT OR THAT THE LIFEBAND IS TWISTED. UPON REPLACEMENT OF THE FRONT COVER, THE PLATFORM WAS RE-EVALUATED THROUGH FUNCTIONAL TESTING AND PASSED ALL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON 10/15/2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE DOWNLOADING DATA FROM THE AUTOPULSE PLATFORM, MULTIPLE USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION) MESSAGES WERE OBSERVED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED. PLEASE NOTE THAT THE EVENT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682895 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1