BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4760252 · Received May 8, 2015

    Report

    Report Number
    3010617000-2015-00261
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE OBSERVED. THE PLATFORM WAS FUNCTIONALLY TESTED AND THE REPORTED COMPLAINT COULD NOT BE DUPLICATED. UNRELATED TO THE REPORTED COMPLAINT OF THE PLATFORM STOPPING AND RESETTING, INSPECTION OF THE DEVICE IDENTIFIED THAT THE LOAD CELL AMP CABLING NEEDED TO BE REPLACED. A REVIEW OF THE ARCHIVE WAS PERFORMED NO USER ADVISORIES WERE OBSERVED ON THE REPORTED EVENT DATE. DURING THE PROCESS OF DOWNLOADING THE ARCHIVE HOWEVER, A DEVICE SELF-RESET WAS OBSERVED THUS DUPLICATING AND CONFIRMING THE REPORTED COMPLAINT. A PROBABLE CAUSE FOR THE DEVICE RE-SET WAS DETERMINED TO BE THAT THE PROCESSOR PCA ASSEMBLY WAS DEFECTIVE. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE LOAD CELL AMP CABLING AND THE PROCESSOR PCA ASSEMBLY. IN SUMMARY, THE REPORTED COMPLAINT WAS DUPLICATED AND CONFIRMED DURING THE PROCESS OF DOWNLOADING THE ARCHIVE DATA FOR REVIEW AND IS ATTRIBUTED TO THE PROCESSOR PCA ASSEMBLY BEING DEFECTIVE. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE PROCESSOR PCA ASSEMBLY AND LOAD CELL AMP CABLING, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A CARDIAC ARREST PATIENT, THE AUTOPULSE PLATFORM CONTINUED TO STOP AND RESET. THE CUSTOMER REPORTED THAT NO ERROR CODES WERE OBSERVED ON THE LCD DISPLAY. INFORMATION REGARDING PATIENT OUTCOME WAS NOT PROVIDED, HOWEVER NO ADVERSE PATIENT SEQUELAE WAS REPORTED. THE CUSTOMER ALSO REPORTED THAT THE WIRE RESTRAINTS NEED TO BE REPLACED. NO FURTHER DETAILS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302562 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1