BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS H/HM (HM3000) SYSTEM

    MDR report key: 1888225 · Received October 20, 2010

    Report

    Report Number
    3003768277-2010-00251
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZF
    PMA / PMN Number
    K925302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO FDA.

    Description of Event or Problem · 1

    THIS X-RAY SYSTEM HAD A BURNING SMELL COMING FROM THE CONSOLE MONITOR. THE VIEWING SUBSTATION (VISUB) BLEW A FUSE. THE VISUB BECAME INOPERABLE. THERE WAS NO PT IN THE ROOM AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS H/HM (HM3000) SYSTEM IZF (SYSTEM, X-RAY, TOMOGRAPHIC) IZF PHILIPS MEDICAL SYSTEMS 72239 NA

    Patients

    Seq Age Sex Outcome Treatment
    1