BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOST 94

    MDR report key: 1942900 · Received December 17, 2010

    Report

    Report Number
    3003768277-2010-00375
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    K912470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DOES NOT DELIVER ENOUGH DOSES. IN ADDITION, SYSTEM DISPLAYED SEVERAL ERROR CODES AND FLUOROSCOPY WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOST 94 JAA (X-RAY FLUOROSCOPIC, IMAGE INTENSIFIED, SYSTEM) JAA PHILIPS MEDICAL SYSTEMS 70851 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA