BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS

    MDR report key: 7984277 · Received October 19, 2018

    Report

    Report Number
    9617251-2018-00002
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    August 29, 2018
    Report Date
    October 15, 2018
    Manufacturer
    SEDECAL SA
    Product Code
    IZL
    UDI-DI
    08436046002173
    PMA / PMN Number
    K141895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS IS A MOBILE DIAGNOSTIC X-RAY UNIT. THE COLLIMATOR ON THE UNIT WAS SERVICED. AS A RESULT OF IMPROPER RE-ATTACHMENT, THE COLLIMATOR FELL OFF THE TUBE-HEAD DURING SUBSEQUENT USE. IT WAS THEN LEFT DANGLING BY ITS CABLE. NO ONE WAS INJURED. A SERVICE PERSON SUBSEQUENTLY RE-ATTACHED THE COLLIMATOR IN A PROPER FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823268 PHILIPS MOBILE DIAGNOSTIC X-RAY SYSTEM IZL SEDECAL SA MOBILEDIAGNOST WDR 08436046002173

    Patients

    Seq Age Sex Outcome Treatment
    1