BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3159148 · Received June 3, 2013

    Report

    Report Number
    3003793491-2013-00664
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: THE REPORTED PROBLEM WAS CONFIRMED IN THE ARCHIVE DATA. THE ARCHIVE DATA SHOWS SEVERAL UA02 (COMPRESSION TRACKING ERROR). THIS ERROR TYPICALLY OCCURS IF PATIENT IS MISALIGNED ON THE AUTOPULSE OR IF THE LIFEBAND IS OPENED. IT ALSO SHOWS UA18 (MAX TAKE-UP REVOLUTIONS EXCEEDED), WHICH MEANS THAT NO LOAD CHANGE WAS DETECTED AT THE LOAD PLATE. THIS ERROR TYPICALLY OCCURS WHEN THERE IS NO PATIENT OR WHEN PATIENT IS TOO SMALL. UA07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS ALSO OBSERVED IN THE ARCHIVE DATA. THIS ERROR TYPICALLY OCCURS DUE TO PATIENT/PLATFORM MOVEMENT DURING THE COMPRESSION. THE PLATFORM RAN WITH A 95% PATIENT TEST FIXTURE USING A GOOD BATTERY FOR AN HOUR WITH NO FAULTS OR ERRORS. THE PLATFORM PASSED FINAL TEST. A PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE COULD BE DUE TO USER ERROR. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PLACING AN UNRESPONSIVE CARDIAC ARREST PT ON THE AUTOPULSE PLATFORM, THE UNIT ADVISED "BAND HAD TO RAISED"; HOWEVER, THE LIFEBAND WAS ALREADY RAISED. ON THE SECOND ATTEMPT, THE UNIT ADVISED "PT HAD TO BE ALIGNED"; HOWEVER, THE PT WAS PROPERLY ALIGNED. THE UNIT WOULD NOT PERFORM COMPRESSIONS ON BOTH ATTEMPTS AND WAS REMOVED FROM THE PT. MANUAL CPR WAS PERFORMED DURING TRANSPORT. THE PT DIED. ADDITIONAL INFO RECEIVED ON (B)(6) 2013: THE PT DIED THE SAME DAY AND THE CAUSE OF DEATH WAS CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243414 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION INC 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUAL CPR