BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® PLATFORM RESUSCITATION

    MDR report key: 8363852 · Received February 22, 2019

    Report

    Report Number
    3010617000-2019-00149
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111000512
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF DRIVE SHAFT DOES NOT TURN WHEN THE LIFEBAND PIN WAS INSTALLED ON THE AUTOPULSE PLATFORM (SN (B)(4)) WAS CONFIRMED DURING VISUAL INSPECTION. EXAMINATION OF THE RETURNED AUTOPULSE PLATFORM FOUND THAT THE DRIVE SHAFT WAS EXHIBITING BINDING AND RESISTANCE CAUSED BY A BURR IN THE CLUTCH PLATE. A CLUTCH PLATE DEBURRING WAS PERFORMED; HOWEVER, THE DRIVE SHAFT STILL DOES NOT ROTATE FREELY. THE AUTOPULSE PLATFORM WAS REPLACED WITH A NEW CLUTCH PLATE TO RESOLVE THE REPORTED ISSUE. THE INVESTIGATION FINDINGS REVEALED THAT THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS DUE TO A DEFECTIVE CLUTCH PLATE. NO PHYSICAL DAMAGE ON THE AUTOPULSE PLATFORM WAS OBSERVED DURING VISUAL INSPECTION. DURING ARCHIVE DATA REVIEW, NO SIGNIFICANT DISCREPANCY IDENTIFIED. AFTER PART REPLACEMENT, THE PLATFORM WAS FUNCTIONALLY TESTED AND OPERATED AS INTENDED WITH NO FURTHER ISSUE OBSERVED. THE DEVICE PASSED ALL FINAL SPECIFICATION. THE AUTOPULSE PLATFORM IS READY FOR CLINICAL USE. HISTORICAL RECORDS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND NO SIMILAR COMPLAINT WAS REPORTED FOR THE AUTOPULSE PLATFORM WITH SERIAL NUMBER (B)(4). BASED ON ZOLL MEDICAL SAFETY ASSESSMENT, THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE AUTOPULSE IS USED AS AN ADJUNCT TO MANUAL CPR IN CASES OF CLINICAL DEATH. THE BENEFIT OF USING THE AUTOPULSE IS THAT IT IN PART SUBSTITUTES MECHANICAL COMPRESSIONS FOR THE PHYSICAL LABOR OF MANUAL CHEST COMPRESSIONS. IF THE AUTOPULSE DID NOT START OR UNEXPECTEDLY STOPS COMPRESSIONS, RESCUER SHOULD REVERT TO MANUAL CPR, WHICH IS THE STANDARD OF CARE. OUT-OF-HOSPITAL CARDIAC ARREST (OHCA) IS ONE OF THE MAIN CAUSES OF DEATH IN INDUSTRIAL NATIONS. ABOUT 25% OF PATIENTS SURVIVE THIS EVENT AND MAKE IT TO THE HOSPITAL, AND EVEN FEWER PATIENTS SURVIVE AFTER 24 HOURS (NICHOL, NEJM, 2015). IN THE UNITED STATES, SURVIVAL TO HOSPITAL DISCHARGE AFTER NON-TRAUMATIC EMERGENCY MEDICAL SERVICES-TREATED CARDIAC ARREST WITH ANY FIRST RECORDED RHYTHM WAS 10.6% FOR PATIENTS OF ANY AGE. OF THE BYSTANDER-WITNESSED OUT-OF-HOSPITAL CARDIAC ARRESTS IN 2011, 31.4% OF VICTIMS SURVIVED TO HOSPITAL DISCHARGE (MOZAFFARIAN, CIRCULATION, 2016). DEATH IS AN EXPECTED OUTCOME FOR OHCA.

    Description of Event or Problem · 1

    DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL # (B)(4)) FUNCTIONED PROPERLY FOR ABOUT 15 TO 20 MINUTES AND THEN THE SHAFT DOES NOT TURN WHEN THE LIFEBAND PIN WAS INSTALLED. THE ISSUE OCCURRED WHILE TREATING A MALE PATIENT AFTER HE HAD BEEN DELIVERED TO THE EMERGENCY DEPARTMENT (ED).THE MALE PATIENT OF UNKNOWN AGE IN CARDIAC ARREST WHO WAS DESCRIBED LARGE - BUT WELL UNDER THE 300 LBS. LIMIT OF THE AUTOPULSE PLATFORM. AFTER A SHORT PERIOD OF MANUAL CPR, THE ED APPLIED THEIR OWN AUTOPULSE PLATFORM TO TREAT THE PATIENT. THE PATIENT NEVER ATTAINED ROSC AND WAS PRONOUNCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156174 AUTOPULSE® PLATFORM RESUSCITATION CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100 00849111000512

    Patients

    Seq Age Sex Outcome Treatment
    1