BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPII

    MDR report key: 3050251 · Received April 5, 2013

    Report

    Report Number
    3009542956-2013-00005
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    February 15, 2013
    Report Date
    April 5, 2013
    Manufacturer
    PHILIPS BURTON
    Product Code
    FQP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT HAS NOT YET BEEN RETURNED TO PHILIPS BURTON FOR ANALYSIS. AFTER SPEAKING WITH THE FACILITY, IT APPEARS THAT IMPROPER MAINTENANCE WAS PERFORMED. MANUALS WHICH ARE PROVIDED TO THE CUSTOMERS WITH EACH DEVICE, IN PARTICULAR, 10008470 A06 OP CS INFO FOR USE MANUAL, PAGE 40- SEC 9.0 HAS A MAINTENANCE SCHEDULE. AS PART OF THE WEEKLY CHECKS: TO OBSERVE IF THE LAMPS SWING EASILY THROUGH THEIR ARC (BUT ARE PREVENTED FROM SWINGING THROUGH 360 DEGREES BY BUILT IN STOPS OR OTHER ARMS)? IF THE ANSWER IS NO, DO NOT USE THE PRODUCT. CONSULT YOUR MAINTENANCE PERSONNEL BEFORE OPERATING THE LIGHT. AS PART OF THE MONTHLY CHECKS: CHECK TIGHTNESS OF SET SCREWS HOLDING THE DOWN TUBE TO THE CEILING CASTINGS. REMOVE THE OUTER COVER BY LOOSENING THE LOCK RING (COLLAR), SLIDE THE COVER DOWN THE TUBE TO GIVE ACCESS TO THE CEILING CASTINGS. CHECK TIGHTNESS OF SCREWS HOLDING THE TRANSITION/PIVOT ASSEMBLY TO THE DOWN TUBE (IF LOOSE ARM/LIGHT COULD DROP). TIGHTEN SCREW WITH AN ALLEN WRENCH. AS PART OF THE ANNUAL CHECKS: HORIZONTAL ARM AND THE LIGHT ARM. (IF WORN, ARM COULD LIFT OUT OF SUPPORT. CHECK TO SEE THAT RETAINER PLUG IS SEATED IN MATING GROOVE OF SUPPORT. (IF LOOSE ARM COULD LIFT OUT OF SUPPORT).

    Description of Event or Problem · 1

    ON (B)(6) PHILIPS BURTON REC'D A COMPLAINT STATING THAT ONE OF OUR SINGLE CEILING LIGHT HAD DETACHED. THE STAFF HAD NOTICED THAT THE LIGHT HAD SHIFTED POSITION AND WERE AWARE THAT CAUTION NEEDED TO BE OBSERVED. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139647 OPII OUTPSTIENT II SINGLE CEILING FQP PHILIPS BURTON 0224100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA