BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3920340 · Received July 8, 2014

    Report

    Report Number
    3003793491-2014-00327
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO ZOLL (B)(4) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND NO PHYSICAL DAMAGES WERE OBSERVED. THE PLATFORM WAS UNABLE TO UNDERGO INITIAL FUNCTIONAL TESTING, AS IT EXHIBITED A USER ADVISORY (UA) 27 (ENCODER FAULT (> 3000 RPM)) AFTER A FEW COMPRESSIONS. IT WAS DETERMINED THAT THE ENCODER GEARBOX WAS DEFECTIVE. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO USER ADVISORY CODES WERE OBSERVED ON THE REPORTED EVENT DATE OF (B)(6) 2014. HOWEVER MULTIPLE UA27 CODES WERE SEEN ON (B)(6) 2015. THE ARCHIVE DATA DID NOT CAPTURE ANY USER ADVISORY 21 CODES. THEREFORE, THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION NO PARTS WERE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A USER ADVISORY 21 MESSAGE. THE ENCODER GEARBOX WAS HOWEVER, WAS REPLACED TO REMEDY THE USER ADVISORY 27 MESSAGE THAT OCCURRED DURING FUNCTIONAL TESTING. IN SUMMARY, THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE ERROR WAS NOT RECORDED IN THE ARCHIVE AND WAS UNABLE TO BE REPRODUCED DURING FUNCTIONAL TESTING. THEREFORE, A ROOT CAUSE FOR THE REPORTED UA 21 COULD NOT BE DETERMINED. FOLLOWING SERVICE, THE DEVICE PASSED ALL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL (B)(4). ZOLL (B)(4) CONFIRMED THE CUSTOMER'S REPORTED COMPLAINT. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A DEVICE CHECK, THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY 21 (POSITION CHANGE DOES NOT COINCIDE WITH MOTOR DIRECTION) MESSAGE AND THEREFORE WOULD NOT OPERATE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397413 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1