BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3150017 · Received May 20, 2013

    Report

    Report Number
    3003793491-2013-00580
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION 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.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED WITH A DEMO MANIKIN AND THE LARGE RESUSCITATION TEST FIXTURE (EQUIVALENT TO 250 POUND PATIENT) AND USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) FAULT WAS OBSERVED REPEATEDLY. FURTHER INSPECTION CONFIRMED A DEFECTIVE DRIVETRAIN LIKELY LED TO THIS FAULT, HOWEVER A DEFINITIVE ROOT CAUSE FOR THE DRIVETRAIN FAILING COULD NOT BE DETERMINED. A REVIEW OF THE ARCHIVE WAS ALSO PERFORMED AND CONFIRMED MULTIPLE INSTANCES OF THE FOLLOWING FAULTS: USER ADVISORY 2 (COMPRESSION TRACKING ERROR), USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION), AND USER ADVISORY 19 (MAX APPLIED LOAD EXCEEDED). IT SHOULD BE NOTED THAT ALTHOUGH THE ARCHIVE DID NOT SHOW ANY FAULTS ON THE REPORTED EVENT DATE, THE REPORTED COMPLAINT HAS BEEN CONFIRMED BASED ON THE ARCHIVE INDICATING MULTIPLE FAULTS THAT DID OCCUR WHILE THE UNIT WAS IN THE FIELD. A DEFINITIVE CAUSE FOR THESE FAULTS COULD NOT BE DETERMINED BASED ON THE EVALUATION OF THE RETURNED PLATFORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM HAS BEEN TAKEN OUT OF SERVICE DUE TO MULTIPLE REPORTS OF LOW RUN TIMES AND USER ADVISORY (UA) ERROR CODES. CUSTOMER DOES NOT RECALL EXACTLY WHICH ERROR CODES. NO ADVERSE PT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221551 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1