BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3182672 · Received June 11, 2013

    Report

    Report Number
    3003793491-2013-00689
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION CONFIRMED FRONT AND BOTTOM ENCLOSURES WERE DAMAGED. DURING FUNCTIONAL EVAL OF THE RETURNED PLATFORM, THE CUSTOMER REPORTED ISSUE OF USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS CONFIRMED. REVIEW OF THE DATA ARCHIVE CONFIRMED THAT MULTIPLE USER ADVISORY (B)(4) FAULTS WERE ENCOUNTERED. FURTHER INSPECTION CONFIRMED THAT A DEFECTIVE SINGLE POINT LOAD CELL MAY HAVE CAUSED THE REPORTED ISSUE. A DEFINITIVE CAUSE; HOWEVER, COULD NOT BE DETERMINED. REVIEW OF COMPLAINT TRENDS DOES NOT SUGGEST ANY INCREASE IN TREND. NO ADD'L INFO NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PREPARING THE AUTOPULSE PLATFORM FOR PT CARE, THE USER FOUND A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE THAT COULD NOT BE CLEARED. THIS PROBLEM DID NOT NEGATIVELY AFFECT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264948 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1