BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALM PRISMATIC

    MDR report key: 154797 · Received March 5, 1998

    Report

    Report Number
    2027060-1998-00001
    Event Type
    Malfunction
    Date Received
    March 5, 1998
    Date of Event
    February 5, 1998
    Report Date
    March 5, 1998
    Manufacturer
    ALM SA PARC DE LIMERE
    Product Code
    FQP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON 2/5/98, A SMALL AREA OF PAINT FROM THE ALM PRC LIGHT CHIPPED AND FELL INTO THE SURGICAL FIELD. THE HOSP REQUESTED THAT CO'S PROJECT AND TECHNICAL SPECIALISTS MEET WITH THE HOSP TO INSPECT THE LIGHT. THIS TOOK PLACE ON 2/7/98. UPON INSPECTION, IT WAS NOTED THAT THE PAINT HAD CHIPPED FROM AN ISOLATED AREA OF THE LIGHTHEAD SUPPORT ARM SYSTEM WHICH SEEMED TO HAVE BEEN SUBJECTED TO CONTINUOUS IMPACT OVER TIME. THIS SURGICAL LIGHT IS APPROX 4 YRS, 10 MONTHS OLD. A REPLACEMENT SUPPORT ARM WAS SENT FROM CO'S FACILITY ON 2/13/98 TO ELIMINATE FURTHER PROBLEMS. CO SUGGESTED THAT THE HOSP REFURBISH THEIR OLDER LIGHTING SYSTEMS AND UNDERGO FURTHER IN SERVICING ON PROPER POSITIONING OF SURGICAL LIGHTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM PRISMATIC SURGICAL LIGHTING FQP ALM SA PARC DE LIMERE 555012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *