BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2920230 · Received December 17, 2012

    Report

    Report Number
    3003793491-2012-00509
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF USER ADVISORY (UA) 27 (ENCODER FAULT [>3000 RMP]) WAS CONFIRMED. HOWEVER, UA 46 (SOFTWARE ERROR) WAS NOT VERIFIED AND WAS NOT SEEN IN THE ARCHIVE FILE. THE REASON FOR THE UA27 MESSAGE WAS THAT THE INTEGRATED ENCODER GEARBOX SCREWS WERE LOOSE. SCREWS WERE TIGHTENED, ISSUE WAS RESOLVED. PLATFORM WAS RUN WITH A MANIKIN FOR 30 MINUTES AND WITH THE LARGE RESUSCITATION TEST FIXTURE (EQUAL TO A 250 POUND PATIENT) FOR 10 MINUTES WITHOUT ANY ISSUES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ON-SITE INSPECTION OF THE PLATFORM, UA27 AND UA46 WERE SEEN WHILE TAKING THE LIFEBAND UP. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1