BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3885116 · Received June 19, 2014

    Report

    Report Number
    3003793491-2014-00288
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT THE PLATFORM WORKED FINE WITH A TEST MANNEQUIN. THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 06/05/2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR THE RETURNED PLATFORM AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE FRONT COVER WAS CRACKED AND THE BATTERY CLIP WAS BENT. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED EVENT OF USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) FAULTS. THE DAMAGES APPEAR TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN OCTOBER OF 2010). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF UA 7 FAULTS WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT UA 7 FAULTS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. ADDITIONALLY, THE ARCHIVE ALSO SHOWS THAT UA 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED), UA 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION), UA 12 (LIFEBAND NOT PRESENT) AND UA 2 (COMPRESSION TRACKING ERROR) MESSAGES OCCURRED ON THE REPORTED EVENT DATE. THESE USER ADVISORIES ARE NOT RELATED TO THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE OF UA 7 FAULTS COULD NOT BE REPRODUCED. THE PLATFORM PASSED THE INITIAL SYSTEM TEST. LOAD CELL CHARACTERIZATION TESTING WAS PERFORMED AND INDICATED THAT THE LOAD CELLS WERE WORKING PROPERLY. THE PLATFORM WAS SUBJECTED TO ADDITIONAL TESTING WITH A 95% PATIENT TEST FIXTURE WITH GOOD BATTERIES FOR SEVERAL HOURS AND NO FAULTS OR ERRORS WERE OBSERVED. BASED ON THE INITIAL INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE FRONT COVER AND THE BATTERY CLIP. IN SUMMARY, THE REPORTED COMPLAINT OF UA 7 FAULTS WAS CONFIRMED BASED ON THE ARCHIVE REVIEW BUT NOT DURING FUNCTIONAL TESTING. THE ROOT CAUSE FOR UA 7 COULD NOT BE DETERMINED. HOWEVER, USER ADVISORY 7 IS AN INDICATION THAT THE PATIENT OUT OF POSITION OR THE PATIENT IS NOT PROPERLY CENTERED. THE OTHER USER ADVISORIES (12, 17, 2, AND 18) OBSERVED IN THE ARCHIVE ARE UNRELATED TO THE REPORTED COMPLAINT. THE ROOT CAUSE FOR THESE USER ADVISORIES COULD NOT BE DETERMINED. HOWEVER, USER ADVISORY 18 IS AN INDICATION THAT THE AUTOPULSE® HAS DETECTED THAT EITHER THE PATIENT'S CHEST IS TOO SMALL WHILE SIZING THE PATIENT (TAKE-UP) OR THAT THERE IS NO PATIENT ON THE PLATFORM. USER ADVISORY 12 IS AN INDICATION THAT THE AUTOPULSE HAS DETECTED THAT THE LIFEBAND IS NOT PROPERLY INSTALLED. USER ADVISORY 2 IS AN INDICATION THAT THE AUTOPULSE® HAS DETECTED A CHANGE IN LIFEBAND TENSION. THIS ADVISORY CAN HAPPEN WHEN THE PATIENT OR LIFEBAND IS OUT OF POSITION, OR IF THE LIFEBAND IS OPENED DURING ACTIVE OPERATION. USER ADVISORY 17 IS AN INDICATION THAT THE LIFEBAND IS TWISTED OR BATTERY VOLTAGE IS LOW. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE UNRELATED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE INITIAL CALL CAME IN ON (B)(6) 2014 FOR AN (B)(6) MALE PATIENT IN CARDIAC ARREST. THE INCIDENT OCCURRED AT THE PATIENT'S RESIDENCE. PATIENT WAS DOWN FOR AN UNKNOWN LENGTH OF TIME. THE ARREST WAS NOT WITNESSED AND BYSTANDER CPR WAS NOT PERFORMED. THE AUTOPULSE PLATFORM WAS DEPLOYED IMMEDIATELY WITHOUT ANY ISSUES. THE PLATFORM RAN FOR A MINUTE OR TWO AND THEN DISPLAYED A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. CUSTOMER REPOSITIONED THE PATIENT AND PULLED THE LIFEBAND COMPLETELY UP. THE PLATFORM WAS RESTARTED IN 15-20 SECONDS. THE PLATFORM CONTINUED COMPRESSIONS FOR TWO MINUTES AND THEN STOPPED WITH THE SAME USER ADVISORY 7 MESSAGE. CUSTOMER PULLED THE LIFEBAND COMPLETELY UP AND RESTARTED THE PLATFORM AGAIN. THE PLATFORM PERFORMED COMPRESSIONS (EXACT LENGTH OF TIME WAS NOT PROVIDED) AND THEN STOPPED WITH ANOTHER USER ADVISORY 7 MESSAGE. THE PATIENT WAS KEPT ON THE AUTOPULSE PLATFORM AND MOVED TO THE COT USING A TARP. HOWEVER, IT IS UNKNOWN IF THE AUTOPULSE WAS PERFORMING COMPRESSIONS WHILE THE PATIENT WAS BEING MOVED. CUSTOMER STATED THAT SHOULDER RESTRAINTS AND HEAD IMMOBILIZERS WERE USED. MANUAL CPR WAS INITIATED FOR 10 MINUTES AFTER THE AUTOPULSE STOPPAGE. THE PATIENT WAS TRANSPORTED TO A HOSPITAL THAT WAS LESS THAN 5 MILES AWAY, IN 4 MINUTES AND 36 SECONDS. MANUAL CPR WAS CONTINUED DURING TRANSPORT IN ADDITION TO ADMINISTRATION OF EPINEPHRINE AND AMIODARONE. CUSTOMER DOES NOT KNOW WHAT WAS DONE AT THE HOSPITAL. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NEVER ACHIEVED. PATIENT EXPIRED ON THE SAME DAY. THE CAUSE OF DEATH IS UNKNOWN AND AN AUTOPSY WAS NOT PERFORMED. HOWEVER, PATIENT DID HAVE A HISTORY OF CARDIAC ISSUES. CUSTOMER DOES NOT ATTRIBUTE THE PATIENT'S DEATH TO THE USE OF THE AUTOPULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361286 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR