BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2665515 · Received July 16, 2012

    Report

    Report Number
    3003793491-2012-00007
    Event Type
    Other
    Date Received
    July 16, 2012
    Date of Event
    March 18, 2012
    Report Date
    July 13, 2012
    Manufacturer
    ZOLL CIRCULATION INC.
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT DID NOT DIE BECAUSE OF THE AUTOPULSE STOPPAGE. THE PT WAS IN CARDIAC ARREST PRIOR TO THE USE OF CPR FOR UNK REASON. ALSO, THE AUTOPULSE IS NOT A STANDALONE THERAPY PER THE APPROVED INDICATION FOR USE. IT IS ADJUNCT TO MANUAL CPR. OUR OPERATOR'S MANUAL CLEARLY ADVISES THE USERS TO SWITCH TO MANUAL CPR IF THE AUTOPULSE STOPS FOR ANY REASON. HOWEVER, IN THIS CASE THE USERS DID NOT PROVIDE MANUAL CPR TO THE PT. BASED ON THE PROBLEM DESCRIPTION SUCH MESSAGE APPEARS WHEN THE LIFEBAND IS NOT PROPERLY INSTALLED OR IF DURING THE INSTALLATION THE ENCODER SHAFT WAS NOT AT THE HOME POSITION. THE SHAFT CAN BE BROUGHT TO HOME POSITION BY PULLING THE LIFEBAND STRAIGHT UP AFTER INSTALLATION. THE AUTOPULSE USER'S MANUAL INCLUDES CLEAR INSTRUCTIONS REGARDING THE INSTALLATION OF THE LIFEBAND AND SPECIFIES PULLING OF THE LIFEBAND PRIOR TO TURNING THE AUTOPULSE ON. IT APPEARS THAT THE USER FAILED TO FOLLOW THE INSTRUCTIONS. WE ARE NOT ABLE TO ANALYZE THE LIFE BAND OR THE AUTOPULSE SINCE THE CUSTOMER CHOSE NOT TO RETURN THE DEVICES BACK. ALSO, THIS DEVICE HAS NEVER BEEN RETURNED FOR YEARLY PREVENTIVE MAINTENANCE AS RECOMMENDED.

    Description of Event or Problem · 1

    IN ORDER TO ACHIEVE A CARDIAC MASSAGE ON A PT OF (B)(6) IN CARDIOPULMONARY ARREST (BETA BLOCKERS POISONING), THE AUTOPULSE HAS BEEN SET UP BY AN EXPERIENCED USER. WHEN THE AUTOPULSE WAS TURNED ON, THE ERROR MESSAGE "PROBLEM LIFEBAND" ASSOCIATED WITH A RED LED APPEARED. THE LIFEBAND WAS A NEW ONE. AFTER PRESSING THE START BUTTON, THE COMPRESSIONS HAD NEVER WORKED, DID NOT ACHIEVE THE CPR. TEN DAYS AGO, THE SAME PROBLEM HAD BEEN OBSERVED, AFTER 10 RESTARTS, THE DEVICE WORKED. NO CPR. PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DTQ ZOLL CIRCULATION INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other