BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMLED

    MDR report key: 3032695 · Received March 29, 2013

    Report

    Report Number
    3009542956-2013-00003
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    PHILIPS BURTON
    Product Code
    FSY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, A HARDWARE PACK (B)(4) AND THE LOCKING CLIP (B)(4) WAS SENT TO THE SITE. ON (B)(4) 2013, AN E-MAIL WAS SENT TO PHILIPS, STATING THAT THE DEVICE WAS REINSTALLED. "IT LOOKS LIKE THE PERSON THAT INSTALLED IT DID NOT ROTATE THE COLLER 180 DEGREES. THE SET SCREW WAS SCREWED INTO THE ARM NO THE HEAD. THE AIMLED, SINGLE CEILING LIGHT WAS RE-INSTALLED CORRECTLY AND IT IS SECURE NOW." THIS E-MAIL CONFIRMED THAT THIS CASE WAS IN FACT AN INSTALLATION ERROR, MADE BY THE INSTALLERS, THAT WERE EITHER CONTRACTORS OR EMPLOYEES OF (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), PHILIPS (B)(4) RECEIVED A COMPLAINT STATING THAT AN AIMLED, SINGLE CEILING LIGHT HAD FALLEN. THE NURSE REPORTS THAT SHE WAS ASKED TO MOVE THE LIGHT. WHEN SHE DID THE LIGHT CAME APART FROM THE ARM AND FELL. FURTHERMORE, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130671 AIMLED AIMLED SINGLE CEILING FSY PHILIPS BURTON ALEDSC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA