BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4221952 · Received November 3, 2014

    Report

    Report Number
    3010617000-2014-00589
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE AUTOPULSE PLATFORM IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE BATTERY LOCK WAS MISSING. THE LOAD PLATE SCREWS WERE FOUND TO BE LOOSE AND NEEDED TO BE RE-TORQUED, THUS CONFIRMING THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED WITH A LARGE RESUSCITATION TEST FIXTURE (EQUIVALENT TO A 250 POUND PATIENT) FOR APPROXIMATELY 10 MINUTES FOLLOWED BY A USER ADVISORY 27 (ENCODER FAULT, > 3000 RPM) BEING DISPLAYED. FURTHER INSPECTION WAS PERFORMED AND THE CAUSE OF THE UA 27 WAS DETERMINED TO BE THAT THE ENCODER GEARBOX WAS NOT FUNCTIONING PROPERLY. A REVIEW OF THE ARCHIVE WAS PERFORMED AND MULTIPLE USER ADVISORY (UA) 27 (ENCODER FAULT, > 3000 RPM), USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RE-START), AND USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) CODES WERE OBSERVED ON THE REPORTED EVENT DATE OF (B)(6) 2014. BASED ON EVALUATION OF THE DEVICE, THE UA 27 CODES ARE ATTRIBUTED TO THE ENCODER GEARBOX NOT FUNCTIONING PROPERLY. THE UA 45 CODES WERE LIKELY DUE TO THE LIFEBAND STRAPS NOT BEING PULLED COMPLETELY OUT PRIOR TO TURNING THE DEVICE ON. THE UA 12 CODES ARE DUE TO THE LIFEBAND BELT CLIP NOT BEING DETECTED IN THE PLATFORM SPOOL SHAFT. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE MISSING BATTERY LOCK. THE LOAD PLATE SCREWS WERE ALSO RE-TORQUED TO REMEDY THE COMPLAINT. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED BASED ON VISUAL INSPECTION AS WELL AS ARCHIVE REVIEW. VISUAL INSPECTION CONFIRMED THAT THE LOAD PLATE SCREWS WERE LOOSE AND NEEDED TO BE RE-TORQUED. THE ARCHIVE DATA ALSO SHOWED THAT MULTIPLE UA CODES OCCURRED ON THE REPORTED EVENT DATE, LEADING TO THE PLATFORM STOPPING OPERATION. BASED ON EVALUATION OF THE DEVICE, THE UA 27 CODES ARE ATTRIBUTED TO THE ENCODER GEARBOX NOT FUNCTIONING PROPERLY. THE UA 45 CODES WERE LIKELY DUE TO THE LIFEBAND STRAPS NOT BEING PULLED COMPLETELY OUT PRIOR TO TURNING THE DEVICE ON. THE UA 12 CODES ARE DUE TO THE LIFEBAND BELT CLIP NOT BEING DETECTED IN THE PLATFORM SPOOL SHAFT.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE® PLATFORM STOPPED AFTER BEING BUMPED. THIS RESULTED IN SOME SCREWS ON THE BACK OF THE PLATFORM, IN THE AREA WHERE THE LIFEBAND IS INSTALLED BECOMING LOOSE. THEREFORE, IT WAS NOT POSSIBLE TO BRING THIS PLATFORM ON A PATIENT CALL. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701540 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1