BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRC 5501 DE

    MDR report key: 116261 · Received August 28, 1997

    Report

    Report Number
    2027060-1997-00006
    Event Type
    Other
    Date Received
    August 28, 1997
    Date of Event
    August 23, 1997
    Report Date
    August 28, 1997
    Manufacturer
    ALM SA
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON 08/25/97 IT WAS REPORTED TO ALM THAT AN ALM LIGHT FIXTURE, MODEL PRC 5501 HAD DROPPED FROM THE CEILING MOUNT ON 08/23/97. ALM IMMEDIATELY DISPATCHED AN ALM TECHNICAN, ALONG WITH A REPLACEMENT LIGHT FIXTURE TO: 1) EVALUATE THE FIXTURE IN QUESTION 2) REPLACE THE FIXTURE SO THE CUSTOMER COULD CONTINUE TO WORK IN THE ROOM. THE LIGHT FIXTURE WAS REPLACED ON 08/26/97 AND THE INITIAL INSPECTION HAS SHOWN THAT SIX NON-REMOVABLE, MACHINE PRESSED PINS HAD SHEARED OFF, CAUSING THE LIGHT TO DETACH FROM THE MOUNT. NO ADDITIONAL INFORMATION CAN BE GIVEN AT THIS TIME AS THE HOSPITAL WILL NOT RELEASE THE LIGHT FIXTURE FOR FURTHER INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRC 5501 DE SURGICAL LIGHT FSY ALM SA 555012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other