BEUDAMED
    FDA Adverse Event Summary report: N

    CEILING MOUNTED EXAM LIGHT

    MDR report key: 20504 · Received March 22, 1995

    Report

    Report Number
    MW1005539
    Date Received
    March 22, 1995
    Date of Event
    January 1, 1995
    Report Date
    March 15, 1995
    Manufacturer
    A.L.M. SURGICAL
    Product Code
    FSY
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL DESIGN OF THESE LIGHTS PROVIDES A STRAIN RELIEF ON EITHER END OF THE POWER CORD TO PREVENT THE CORD FROM PULLING OUT OF THE WIRE ENCLOSURE. THIS DESIGN WAS EVALUATED TO THE APPROPRIATE SAFETY STANDARDS & LISTED BY UL. IN ADDITION, THE HOSP REQUESTED & WAS SUPPLIED WITH ADD'L ROTATIONAL STOPS WHICH WERE INSTALLED IN FEBRUARY. THE LIGHT DESIGN WITH THESE ROTATIONAL STOPS WAS EVALUATED & FOUND TO BE SAFE BY CSA IN 9/91. RPTR BELIEVES THE ACTION REQUIRED FOR THIS COMPLAINT IS TO INSPECT ALL 16 LIGHTS, MAKING SURE THE CORD STRAINS RELIEFS HAVE BEEN INSTALLED CORRECTLY, THE ROTATIONAL STOPS HAVE BEEN INSTALLED CORRECTLY WITH THE SET SCREWS SECURELY TIGHTENED, & TO TRAIN THE APPROPRIATE HOSP PERSONNEL ON THE ALLOWABLE RANGE OF MOTION OF THIS EQUIPMENT & OF THE PROBLEMS ASSOCIATED WITH APPLYING EXCESSIVE FORCE TO EQUIPMENT AFTER IT HAS REACHED ITS ROTATIONAL STOP. SINCE THERE WERE NO INJURIES RESULTING FROM THIS COMPLAINT, RPTR HAS DETERMINED THAT AN MDR IS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEILING MOUNTED EXAM LIGHT FSY A.L.M. SURGICAL 71514

    Patients

    Seq Age Sex Outcome Treatment
    1 *