BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3260375 · Received August 1, 2013

    Report

    Report Number
    3003793491-2013-00762
    Event Type
    Death
    Date Received
    August 1, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND NO SIGNIFICANT DISCREPANCIES WERE FOUND. REVIEW OF THE ARCHIVE DATA INDICATED THAT USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) HAD OCCURRED, THEREBY CONFIRMING THE CUSTOMER'S REPORTED COMPLAINT. FURTHERMORE, LOAD CELL CHARACTERIZATION CONFIRMED THAT LOAD CELL MODULE 2 WAS NOT FUNCTIONING PROPERLY. LOAD CELL MODULE 2 WAS REPLACED AND THE PLATFORM WAS SUBJECTED TO A RUN-IN TEST WITH A 95% PATIENT TEST FIXTURE FOR AN HOUR WITH NO FAULTS OR ERRORS OBSERVED. A ROOT CAUSE FOR THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ZOLL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY (UA) 7 MESSAGE THAT COULD NOT BE CLEARED. CUSTOMER REVERTED TO MANUAL CPR. IT WAS REPORTED THAT THE PATIENT IS DECEASED BUT NOT AS A RESULT OF THE PLATFORM. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2013: CUSTOMER REPORTED THAT THE PATIENT DIED ON (B)(6) 2013. PARAMEDICS ARRIVED ON SCENE TO FIND THE PATIENT PULSELESS. FULL CARDIAC RED ALERT ISSUED. IT IS UNKNOWN HOW LONG THE PATIENT WAS PULSELESS PRIOR TO THE ARRIVAL OF PARAMEDICS. PARAMEDICS DID ATTEMPT TO USE THE AUTOPULSE PLATFORM ON THE PATIENT DURING TRANSPORT, BUT USER ADVISORY 07 CODE CAME UP WHEN THE DEVICE WAS TURNED ON. THE LIFEBAND WOULD NOT RETRACT DOWN ON THE PATIENT AND PLATFORM WOULD NOT DO CHEST COMPRESSIONS. PARAMEDICS REMOVED THE DEVICE AND BEGAN MANUAL CPR. CUSTOMER DOES HAVE ACCESS TO THE AUTOPSY REPORT, HOWEVER, THEY CANNOT RELEASE PATIENT INFORMATION DUE TO HIPAA. PLEASE NOTE THAT THE CUSTOMER REPORTED THIS EVENT ON (B)(6) 2013 AND INDICATED THAT THE PATIENT IS DECEASED. HOWEVER, PER ADDITIONAL INFORMATION RECEIVED ABOVE, CUSTOMER INDICATED THAT THE PATIENT DIED ON (B)(6) 2013. MANUFACTURER HAS REQUESTED FURTHER CLARIFICATION ON THE DATE AND CAUSE OF PATIENT'S DEATH FROM THE CUSTOMER; HOWEVER, NO INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359777 AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUAL CPR