BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3873112 · Received June 13, 2014

    Report

    Report Number
    3003793491-2014-00283
    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

    ZOLL HAS NOT YET RECEIVED THE PRODUCT 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

    AUTOPULSE PLATFORM S/N (B)(4) WAS RETURNED TO ZOLL MEDICAL FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND NO DAMAGES WERE OBSERVED. INITIAL FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND NO FAULTS OR ERRORS WERE EXHIBITED. THE PLATFORM RAN FOR 7 MINUTES WITH A TEST MANNEQUIN AND 3 MINUTES WITH THE LRTF (LARGE RESUSCITATION TEST FIXTURE) AND NO FAULTS OR ERRORS WERE OBSERVED. 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 UA45 (NOT AT "HOME" POSITION"AFTER POWER ON/RESTART) AND UA 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) ERRORS WERE OBSERVED THROUGHOUT THE ARCHIVE. A ROOT CAUSE FOR 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). A ROOT CAUSE OF THE UA 18 ERRORS WAS ALSO UNABLE TO BE ATTRIBUTED TO A SPECIFIC COMPONENT, HOWEVER PER THE BATTERY HANGTAG - ADVISORY CODES DESCRIPTION AND ACTION (PN 12741-001), USER ADVISORY 18 IS AN INDICATION THAT THE AUTOPULSE HAS DETECTED 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 CUSTOMER'S REPORTED COMPLAINT THAT THE PLATFORM WAS STOPPING COMPRESSIONS, TURNING OFF OR SHOWING UNSPECIFIC ERROR MESSAGES WAS CONFIRMED THROUGH REVIEW OF THE PLATFORM ARCHIVES. THE CUSTOMER EXPERIENCING MULTIPLE UA 45 AND UA 18 ERRORS WERE 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 MEDICAL AND ALL PARTS WERE DETERMINED TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE® NEVER WORKED AS IT SHOULD HAVE. COMPLAINANT COULD NOT PROVIDE SPECIFIC DETAILS, BUT INDICATED THAT THERE HAVE BEEN REPORTS OF THE PLATFORM STOPPING COMPRESSIONS, TURNING OFF OR DISPLAYING ERROR MESSAGES. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350005 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1