BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTPATIENT II SINGLE CEILING

    MDR report key: 2507411 · Received March 9, 2012

    Report

    Report Number
    2018492-2012-00004
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    January 31, 2012
    Report Date
    March 7, 2012
    Manufacturer
    PHILIPS BURTON
    Product Code
    FQP
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE OUTPT (B)(4) LIGHT DISCONNECTED FROM THE DOWN TUBE AND FELL ON (B)(6) 2012. THE DOCTOR WAS HOLDING THE LIGHT HANDLE AS IT DETACHED AND HE DEFLECTED THE LIGHT AWAY FROM THE PT. THERE WAS MINIMAL CONTACT WITH THE PT AND THE PT RECEIVED A BRUISE TO HER RIGHT UPPER ARM. THE DOCTOR REPORTED THAT HE SAW THIS PT AGAIN ON (B)(6) 2012 AND STATED "HER RIGHT UPPER ARM HAS A LARGE BRUISE BUT OTHERWISE IS OKAY. I THINK ALL WILL BE FINE." FROM THE PHOTOS SUBMITTED BY THE COMPLAINANT, (B)(6), NOTICED THAT THE UNIT HAD BEEN INSTALLED WITH THE INCORRECT DOWN TUBE. THE DOCTOR STATED THAT THIS WAS THE DOWN TUBE THAT WAS PROVIDED WITH THE UNIT AND THIS IS THE ONLY LIGHT PURCHASED FROM THE (B)(6). THE UNIT HAD RECENTLY BEEN UNINSTALLED, RELOCATED AND RE-INSTALLED. THE UNIT SHOULD HAVE BEEN INSTALLED WITH A SAFETY PIN (THAT IS USUALLY PROVIDED WITH THIS LIGHT DESIGN) TO SECURE THE LIGHT TO THE DOWN TUBE. THE LIGHT HAD BEEN HELD IN PLACE BY ONLY THE SET SCREW. THE FRICTION BETWEEN THE SET SCREW AND THE DOWN TUBE EVENTUALLY GAVE AND THE LIGHT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTPATIENT II SINGLE CEILING FQP PHILIPS BURTON OP216SC

    Patients

    Seq Age Sex Outcome Treatment
    1