BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLED

    MDR report key: 22357281 · Received June 30, 2025

    Report

    Report Number
    9710055-2025-0000171
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Report Date
    June 30, 2025
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: 200115-01 - (B)(6) HOSPITAL. EVENT SITE POSTAL CODE: (B)(6). EVENT SITE TELEPHONE: (B)(6). EVENT SITE ADDRESS LINE 2: (B)(6). THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. INITIAL REPORTER: CLINICAL ENGINEER. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THE PAINT WAS CHIPPING FROM FORK. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHTS DID NOT MEET ITS SPECIFICATION, SINCE PAINT CHIPPING COULD BE CONSIDERED AS TECHNICAL DEFICIENCIES, AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS UNKNOWN IF CLAIMED DEVICES WERE OR WERE NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. A ROOT CAUSE ANALYSIS FOR PAINT PEELING PROBLEM WAS PERFORMED BY SUBJECT MATTER EXPERTS AND CONCLUDED THAT ALL MAQUET SAS PRODUCTS COMPLY WITH: CURRENT VERSION OF IEC 60601-1 GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE. CURRENT VERSION OF IEC 60601-2-41 PARTICULAR REQUIREMENTS FOR THE SAFETY OF SURGICAL LUMINAIRES AND LUMINAIRE FOR DIAGNOSIS. PAINT DEFINITION PFC066. THIS PROCEDURE DEFINES MAQUET SAS¿S REQUIREMENTS FOR ALL PAINTED PARTS. DISINFECTION PRODUCTS TEST: THE AIM OF THESE TESTS IS TO DETECT ANY INCOMPATIBILITY WITH DISINFECTANT. THE PAINT CHIP OR PAINT DAMAGES ARE DUE TO: IMPACTS, COLLISIONS (ABNORMAL USE). THE OPERATING MANUAL INCLUDES THE INSTRUCTIONS TO PRE-POSITION THE ARMS PRIOR TO USE, IN ORDER TO PREVENT DAMAGES. TO PREVENT ANY SIMILAR INCIDENT, IT IS RECOMMENDED TO AVOID COLLISIONS BETWEEN DEVICES. VISUAL INSPECTIONS DURING THE CLEANING ALLOW TO DETECT THE PAINTING DEFECT, WE RECOMMEND TO PERFORM CORRECTIVE MAINTENANCE TO RECTIFY THE DEFAULT AFTER ITS DETECTION. MINOR PAINT CHIP CAN BE REPAIRED WITH TOUCH UP PAINT, NEVERTHELESS, THE PARTS IMPACTED BY SERIOUS DAMAGE MUST BE REPLACED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THE PAINT WAS CHIPPING FROM FORK. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969638 HLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDHLD209000A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown