BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDIAGNOST ELEVA

    MDR report key: 1942853 · Received December 21, 2010

    Report

    Report Number
    3003768251-2010-00075
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    PMA / PMN Number
    K031535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING AND CONCLUSIONS WILL BE SENT IN A FOLLOW UP REPORT BEFORE (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT REPORTED ABOUT A BURNING SMELL FROM THE UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYDIAGNOST ELEVA KPR PHILIPS MEDICAL SYSTEMS KPR NA

    Patients

    Seq Age Sex Outcome Treatment
    1