BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIM

    MDR report key: 3032579 · Received March 29, 2013

    Report

    Report Number
    3009542956-2013-00004
    Event Type
    Other
    Date Received
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    PHILIPS BURTON
    Product Code
    FQP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, A HARDWARE PACK ((B)(4)) WITH THE LOCKING CLIP ((B)(4)) WAS SENT TO THE SITE. ACCORDING TO THE ICF 4135, A (B)(6) TECHNICIAN, (PHILIPS ELECTRICAL CONTRACTOR) HAD MADE A VISIT TO THE SITE AND CONFIRMED THAT THE LOCKING CLIP WAS NOT INSTALLED IN THE UNIT. THIS CONFIRMED WHAT PHILIPS ENGINEERS HAD PREDICTED, THAT THIS CASE WAS IN FACT AN INSTALLATION ERROR, MADE BY THE INSTALLERS, THAT WERE EITHER CONTRACTORS OR EMPLOYEES OF (B)(6). ON (B)(4) 2013 ADDITIONAL PARTS WERE SENT AT THE REQUEST OF (B)(6), AFTER A CONVERSATION WITH THE DESIGN ENGINEERS OF PHILIPS. THE COMPLETE REPAIR AND THE REPORT IS SCHEDULED (B)(4), WITH THE FINAL REPORT FROM (B)(6), TO BE SUBMITTED AT A LATER DATE.

    Description of Event or Problem · 1

    ON (B)(6), PHILIPS BURTON RECEIVED A CALL FROM (B)(6), THE PRACTICE MANAGER, FROM (B)(6) THAT AN AIM-100, SINGLE CEILING LIGHT HAD FALLEN. THE PRACTICE MANAGER REPORTS THAT HE WAS NOT THERE AT THE TIME, BUT CLAIMS THAT THE LIGHT HAD FALLEN HITTING AN LVT. THE LVT WAS INJURED AND REPORTED TO BE BLEEDING AND SUFFERED A POSSIBLE CONCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130277 AIM AIMLED SINGLE CEILING FQP PHILIPS BURTON A100SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA