BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3181702 · Received June 6, 2013

    Report

    Report Number
    3003793491-2013-00666
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE BATTERY PARTITION COVER WAS MISSING. ARCHIVE DATA RESULTS AS FOLLOWS: THERE WERE THREE SESSIONS LISTED ON THE DATE ((B)(6) 2013) OF THE REPORTED COMPLAINT AND THEY ALL USED BATTERY WITH SN (B)(4), WHICH HAS A DATE CODE OF ABOUT (B)(6) 2009. THIS BATTERY IS OVER 3 YEARS OLD. ON THE FIRST SESSION, 64 COMPRESSIONS WERE DONE BEFORE THE UNIT STOPPED WITH A FAULT 2 (PATIENT OUT OF ALIGNMENT). ON THE SECOND SESSION, THE PLATFORM DID 8 COMPRESSIONS BEFORE GIVING A LOW BATTERY WARNING AND STOPPING. THE LAST SESSION GAVE 4 COMPRESSIONS BEFORE STOPPING WITH A LOW BATTERY WARNING. CUSTOMER'S REPORTED PROBLEM WAS NOT CONFIRMED DURING INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED WITH NO PROBLEMS. BASED ON THE EVALUATION RESULTS, A PROBABLE ROOT CAUSE FOR THE CUSTOMER'S REPORTED COMPLAINT MAY BE DUE TO THE BATTERY THAT THE CUSTOMER WAS USING AT THE TIME OF THE COMPLAINT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE NO BATTERIES WERE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PATIENT CARE, THE AUTOPULSE PLATFORM DID NOT WORK AT ALL AFTER ABOUT 8 COMPRESSIONS ON A CALL WITH A KNOWN GOOD BATTERY. CUSTOMER TRIED A DIFFERENT BATTERY AND THE PLATFORM WOULD NOT GIVE ANY MORE COMPRESSIONS. HOWEVER, THERE IS DATA ON THE LCD SCREEN. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252022 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1