BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPII

    MDR report key: 4272008 · Received November 10, 2014

    Report

    Report Number
    3009542956-2014-00004
    Event Type
    Other
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 10, 2014
    Manufacturer
    PHILIPS BURTON
    Product Code
    FSY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NUMBER (B)(4) (REPAIR), DOCUMENTS A (B)(4) TECHNICIAN (PHILIPS ELECTRICAL CONTRACTOR) HAD MADE A VISIT TO THE SITE AND DISCOVERED THAT THE MOUNTING SCREWS WERE LOOSE. NOT PROPERLY INSTALLED (TIGHTENED) DURING INITIAL INSTALLATION. THE DEVICE WAS REMOUNTED WITH SEALED MOUNTING SCREWS WITH LOCTITE AND INSPECTED FOR PROPER INSTALLATION. THE REPORT OF THIS REPAIR WAS SUBMITTED TO PHILIPS ON 15 OCTOBER 2014. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    PHILIPS BUTTON WAS NOTIFIED BY THE CUSTOMER REGARDING AN OPII LIGHT WHICH HAD DETACHED FROM THE CEILING MOUNT. THE FIXTURE GLANCED THE DOCTOR'S BACK. THERE WAS NO INJURY REPORTED, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721612 OPII OUTPATIENT II FSY PHILIPS BURTON OPII NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA