BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMLED SINGLE CEILING

    MDR report key: 3060874 · Received April 9, 2013

    Report

    Report Number
    3009542956-2013-00006
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 8, 2013
    Manufacturer
    PHILIPS BURTON
    Product Code
    FQP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE (B)(4) TECHNICIAN (PHILIPS ELECTRICAL CONTRACTOR) HAD MADE A VISIT TO THE SITE AND CONFIRMED THAT THE LOCKING CLIP WAS NOT INSTALLED IN THE UNIT AS INDICATED IN THE INSTALLATION MANUAL, CONFIRMING THAT THIS CASE WAS IN FACT AN INSTALLATION ERROR, MADE BY THE INSTALLERS, THAT WERE EITHER CONTRACTORS OR EMPLOYEES OF LANCASTER GENERAL HOSPITAL. THE COMPLETE REPAIR AND THE REPORT WAS COMPLETED THE WEEK OF (B)(4) 2013.

    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. IT WAS REPORTED THAT THE UNIT THAT HAD DETACHED HAD STRUCK A CLINICIAN. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144445 AIMLED SINGLE CEILING AIMLED SINGLE CEILING FQP PHILIPS BURTON ALEDSC 10/15/12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA