BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LIFEBAND

    MDR report key: 15547384 · Received October 5, 2022

    Report

    Report Number
    3010617000-2022-01735
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 5, 2022
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    DRM
    UDI-DI
    00849111001571
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "THE LIFEBAND (LOT #170102) SHEARED OFF AT THE LIFEBAND BAND CLIP AND WOULD NOT RETRACT" WAS CONFIRMED DURING THE VISUAL INSPECTION. DUE TO THE LIFEBAND'S SHEATHING BEING TORN AND RIPPED, THE LIFEBAND BELT CLIP IS STUCK IN THE ENCODER SHAFT. THE PROBABLE ROOT CAUSE FOR THE DAMAGE WAS DUE EXCESSIVE USE OF THE LIFEBAND, LIKELY ATTRIBUTED TO USER MISHANDLING. PER THE AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 USER GUIDE, LIFEBAND IS A SINGLE-USE COMPONENT. DISCARD THE LIFEBAND AS IT IS A SINGLE-USE COMPONENT AFTER PATIENT USE. UPON VISUAL INSPECTION, THE AUTOPULSE LIFEBAND'S SHEATHING WAS TORN AND RIPPED AND BOTH SIDES OF THE LIFEBAND LOCKING TAB WERE BROKEN OFF, THUS CONFIRMING THE REPORTED COMPLAINT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED LIFEBAND. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR LIFEBAND WITH LOT#170102. THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE AUTOPULSE IS USED AS AN ADJUNCT TO MANUAL CPR, ADJUNCTIVE USE ONLY INDICATION IS PROMINENTLY DISPLAYED ON DEVICE LABELS AND IN THE DEVICE MANUAL. THE BENEFIT OF USING THE AUTOPULSE IS THAT IT IN PART SUBSTITUTES MECHANICAL COMPRESSIONS FOR THE PHYSICAL LABOR OF MANUAL CHEST COMPRESSIONS WHEN EFFECTIVE MANUAL CPR IS NOT POSSIBLE. IF THE AUTOPULSE DID NOT START OR UNEXPECTEDLY STOPS COMPRESSIONS, RESCUER SHOULD REVERT TO MANUAL CPR, WHICH IS THE STANDARD OF CARE. THE AUTOPULSE IS INTENDED TO BE USED AS AN ADJUNCT TO MANUAL CPR ON ADULT PATIENTS. IN CASE OF STOPPAGE OF AUTOPULSE THE TRAINED USER REVERTS TO MANUAL CPR. THE TRANSITION FROM AUTOPULSE TO MANUAL CPR BY TRAINED USERS IS SIMILAR TO THE TIME NECESSARY FOR RESCUER ROTATION, AND PRESENTS THE SAME WORKFLOW AS MANUAL CPR. HENCE, BASED ON AVAILABLE INFORMATION, THE PATIENTS' OUTCOME WAS NOT NEGATIVELY IMPACTED BY THE INTERRUPTIONS WHEN COMPARED TO STANDARD OF CARE MANUAL CPR. 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 · 0

    DURING USE ON A 44 YEAR OLD FEMALE CARDIAC ARREST PATIENT, THE CUSTOMER REPORTED THE AUTOPULSE PLATFORM SN (B)(4) FAILED DURING COMPRESSIONS. THE CUSTOMER STATES THE LIFEBAND (LOT #170102) SHEARED OFF AT THE LIFEBAND BAND CLIP THAT WAS SEATED IN THE DRIVESHAFT SLOT. THE "REPLACE BATTERY" MESSAGE CAME ON, AND SHORTLY AFTER THE DEVICE STOPPED. THE CUSTOMER QUICKLY CHANGED TO A NEW BATTERY, THE LIFEBAND RESIZED, AND CPR CONTINUED FOR A SHORT TIME. IT WAS APPROXIMATELY FIVE MINUTES AFTER THE BATTERY CHANGE THAT THE ERROR CAME UP ON THE SCREEN THAT THE LIFEBAND NEEDED TO BE EXTENDED, AND RESTART BUTTON PUSHED. THE CUSTOMER TRIED THIS SEVERAL TIMES, EXTENDING THE BAND, PRESSING THE START BUTTON AGAIN, WITH NO RESIZE OR CONTINUATION OF CPR. MANUAL CPR WAS PERFORMED WHILE TROUBLESHOOTING THE ISSUE. AFTER OVER 1 HOUR OF CPR, THE PATIENT WAS PRONOUNCED BY A PHYSICIAN. CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE RELATIONSHIP BETWEEN THE DEATH AND THE ALLEGED MALFUNCTION. HOWEVER, THE MSA EVALUATED THE INCIDENT AND IT WAS DETERMINED THAT THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2022-01733 FOR THE AUTOPULSE PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076644 AUTOPULSE® LIFEBAND CARDIAC RESUSCITATOR BAND DRM ZOLL CIRCULATION INC MODEL 100 170102 00849111001571

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female