BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3872330 · Received June 13, 2014

    Report

    Report Number
    3003793491-2014-00281
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 06/26/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND NO DAMAGES TO THE PLATFORM WERE OBSERVED. INITIAL FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND NO FAULTS OR ERRORS WERE EXHIBITED. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO ANOMALIES WERE NOTED ON OR AROUND THE REPORTED EVENT DATE OF (B)(6) 2014. HOWEVER, MULTIPLE USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) AND UA 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) ERRORS WERE NOTED THROUGHOUT THE ARCHIVE. THE ROOT CAUSE OF THE UA45 ERRORS WAS UNABLE TO BE ATTRIBUTED TO ANY SPECIFIC COMPONENT. THEREFORE, THE ROOT CAUSE OF THE ERROR IS ATTRIBUTED TO THE LIFEBAND NOT BEING PROPERLY PULLED UP PRIOR TO USE (USER ERROR). THE ROOT CAUSE OF THE UA 18 ERRORS WAS ALSO UNABLE TO BE ATTRIBUTED TO A SPECIFIC COMPONENT. THEREFORE, PER THE BATTERY HANGTAG - ADVISORY CODES DESCRIPTION AND ACTION (PN 12741-001), THE ROOT CAUSE IS ATTRIBUTED TO THE AUTOPULSE DETECTING THAT "EITHER THE PATIENT'S CHEST SIZE IS TOO SMALL WHILE SIZING THE PATIENT (TAKE-UP) OR THAT THERE IS NO PATIENT ON THE PLATFORM." THE PLATFORM UNDERWENT AND MET ALL FINAL TESTING CRITERIA. THE CUSTOMER'S REPORTED COMPLAINT THAT THE PLATFORM WAS STOPPING COMPRESSIONS, TURNING OFF OR SHOWING UNSPECIFIC ERROR MESSAGES WAS CONFIRMED THROUGH REVIEW OF THE PLATFORM'S ARCHIVES. THE CUSTOMER EXPERIENCING MULTIPLE UA 45 AND UA 18 ERRORS WAS FOUND THROUGHOUT THE AUTOPULSE ARCHIVE. THE ROOT CAUSE OF THESE ERRORS WAS DETERMINED TO BE USER ERROR AS THE PLATFORM FUNCTIONED AS INTENDED DURING TESTING BY ZOLL AND ALL PARTS WERE DETERMINED TO BE WITHIN SPECIFICATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DID NOT WORK AS IT SHOULD HAVE DUE TO NON-SPECIFIC REPORTS OF STOPPING COMPRESSIONS, TURNING OFF OR DISPLAYING ERROR MESSAGES. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350052 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1