BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYDIAGNOST ELEVA

    MDR report key: 1912449 · Received November 12, 2010

    Report

    Report Number
    3003768251-2010-00051
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    PMA / PMN Number
    K031535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD/RESULTS/CONCLUSIONS - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. ((B)(4)).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN AND PRODUCED A BURNING SMELL. UPON INSPECTION IT WAS CONFIRMED THE UPS (POWER SUPPLY) HAD BURNED. THE UPS WAS BY-PASSED TO GET SYSTEM UP AND RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYDIAGNOST ELEVA KPR PHILIPS MEDICAL SYSTEMS 706032 NA

    Patients

    Seq Age Sex Outcome Treatment
    1