BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3150033 · Received May 20, 2013

    Report

    Report Number
    3003793491-2013-00579
    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)(4) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND REVEALED NO DAMAGES. FUNCTIONAL TESTING WAS ALSO PERFORMED WITH THE RETURNED PLATFORM. THE PLATFORM RAN FOR 25 MINUTES WITH A MANNEQUIN AND A TEST BATTERY THAT WAS NOT FULLY CHARGED AND HAD NO PROBLEMS. THE PLATFORM THEN RAN FOR 11 MINUTES WITH A FULLY CHARGED TEST BATTERY AND A LARGE RESUSCITATION TEST FIXTURE (EQUIVALENT TO A 250 POUND PATIENT) AND HAD NO PROBLEMS. REVIEW OF ARCHIVE FILES INDICATED THAT THERE WERE NO SESSIONS BETWEEN 04/29/12 AND 02/13/13. FROM 02/13/13 TO 06/03/13, EVERY SESSION THAT HAD COMPRESSIONS DONE LASTED 45 OR MORE MINUTES AND OVER 3000 COMPRESSIONS WERE DONE IN EACH OF THOSE SESSIONS BEFORE LOW BATTERY WARNINGS APPEARED. FROM THE FIRST SESSION LISTED IN THE ARCHIVE FILE TO THE SESSION PERFORMED ON 04/29/12, COMPRESSIONS WERE DONE IN ONLY 6 OF THOSE SESSIONS. THE LONGEST OF THOSE 6 SESSIONS WHERE COMPRESSIONS WERE DONE ONLY LASTED FIVE AND A HALF MINUTES. FURTHER REVIEW OF THE ARCHIVE FILES CONFIRMED THAT THE ERROR MESSAGES THAT APPEARED DURING THOSE SESSIONS WERE EITHER LOW BATTERY INDICATOR MESSAGES OR BATTERY COMMUNICATION ERRORS. THESE ERROR MESSAGES MAY HAVE OCCURRED DUE TO THE BATTERY NOT BEING FULLY CONNECTED, DAMAGED CONNECTING PINS OR A BAD CIRCUIT BOARD INSIDE THE BATTERY. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO BATTERIES WERE RETURNED FOR EVALUATION. BASED ON THE REVIEW OF THE ARCHIVE FILES, THE REPORTED COMPLAINT OF MULTIPLE REPORTS OF USER ADVISORY ERROR CODES WAS CONFIRMED. A DEFINITIVE CAUSE FOR THESE OBSERVED FAULTS COULD NOT BE DETERMINED.

    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
    221514 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1