BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECL 951

    MDR report key: 59538 · Received December 30, 1996

    Report

    Report Number
    2027060-1996-09002
    Event Type
    Other
    Date Received
    December 30, 1996
    Date of Event
    December 5, 1996
    Report Date
    December 18, 1996
    Manufacturer
    ALM HOSP EQUIPMENT
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, A 500MM MAIN ARM SEPARATED FROM THE 900MM MAIN ARM ON A CEILING MOUNTED SURGICAL LIGHT AND FELL TO THE FLOOR. UPON SPEAKING TO THE MGR OF THE ENGINEER AND MAINTENANCE DEPT, THE UNIT WAS REMOVED FROM A SISTER HOSP AND PLACED IN STORAGE, THEN REINSTALLED INTO THE CURRENT OR APPROX IN 1989. THIS WORK WAS COMPLETED WITHOUT MFR'S SUPERVISION BY CONSTRUCTION PERSONNEL DOING OR RENOVATIONS AND NEW CONSTRUCTION WORK FOR THE HOSP. UPON INVESTIGATION BY MFR TECHNICAL SPECIALIST, IT WAS DETERMINED THAT THE EQUIPMENT WAS INSTALLED IMPROPERLY AND NEEDED PERFORMANCE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECL 951 CEILING MOUNTED SURGICAL LIGHT FSY ALM HOSP EQUIPMENT ECL 951 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other