BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3931562 · Received July 14, 2014

    Report

    Report Number
    3003793491-2014-00330
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND A CRACKED HEAD RESTRAINT BRACKET WAS OBSERVED. FROM THE CONDITION OF THE PLATFORM, THE CAUSE OF THE DAMAGE APPEARS TO BE WEAR AND TEAR. THE REPORTED USER ADVISORY (UA) 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGE COULD NOT BE REPRODUCED DURING FUNCTIONAL EVALUATION. THE PLATFORM RAN FOR 10 MINUTES USING A TEST MANIKIN AND AN ADDITIONAL 5 MINUTES WITH A LARGE RESUSCITATION TEST FIXTURE (LRTF) (EQUIVALENT TO A (B)(6) POUND PATIENT), WITH NO ISSUES NOTED. FURTHER INSPECTION OF THE PLATFORM DID NOT FIND THE PATIENT TEMPERATURE SENSOR TO HAVE FAILED, HOWEVER, IT WAS IDENTIFIED AS NEEDING TO BE REPLACED AS A PRECAUTION TO PREVENT FUTURE UA 41 FAULTS FROM OCCURRING. A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A USER ADVISORY 41 (PATIENT TEMPERATURE SENSOR FAILURE) FAULT WAS CONFIRMED. THE ARCHIVE DID NOT SHOW THE FAULT OCCURRING ON THE REPORTED EVENT DATE OF (B)(6) 2014, HOWEVER, THE FAULT DID OCCUR ON (B)(6) 2014. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR PRECAUTIONARY REPLACEMENT IS THE PATIENT TEMPERATURE SENSOR. IN SUMMARY, THE REPORTED COMPLAINT OF A UA 41 FAULT OCCURRING WAS CONFIRMED THROUGH ARCHIVE REVIEW. FURTHER INSPECTION OF THE PLATFORM DID NOT FIND THE PATIENT TEMPERATURE SENSOR TO HAVE FAILED, HOWEVER, IT WAS IDENTIFIED AS NEEDING TO BE REPLACED AS A PRECAUTION TO PREVENT FUTURE UA 41 FAULTS FROM OCCURRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGE THAT COULD NOT BE CLEARED. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409833 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1