BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSERA C-ARM

    MDR report key: 1876149 · Received October 1, 2010

    Report

    Report Number
    MW5017752
    Event Type
    Other
    Date Received
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAK
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHILIPS MEDICAL SYSTEMS SUPPLIES (B)(6) INFO PURSUANT TO 21CFR 1020.30-33 FOR ITS X-RAY PRODUCING DEVICES. THE (B)(6) INFO FOR THE PULSERA C-ARM, (B)(4) AND ULTRA Z CT SCANNERS IDENTIFIES INFO IN THE (B)(6) INFO THAT PHILIPS DID NOT INCLUDE WITH THE (B)(4) INFO. PHILIPS HAS NOT RESPONDED TO A REQUEST FOR THIS INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSERA C-ARM PULSERA C-ARM JAK PHILIPS MEDICAL SYSTEMS SEE ABOVE
    2 BRILLANCE BRILLANCE JAK PHILIPS MEDICAL SYSTEMS SEE ABOVE
    3 ULTRA CT SCANNERS ULTRA CT SCANNERS JAK PHILIPS MEDICAL SYSTEMS SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other