BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLX2004/HLX2003

    MDR report key: 17096834 · Received June 9, 2023

    Report

    Report Number
    9710055-2023-00434
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 9, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, D1 BRAND NAME, D4 SERIAL # AND D4 VERSION OR MODEL # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 26TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE CONFIGURATION OF SURGICAL LIGHTS - HLX 2004. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM THE DEVICE AND THE COVER ON SUSPENSION ARM WAS CRACKED AND TAPED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 26TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE CONFIGURATION OF SURGICAL LIGHTS - HLX 2004 AND HLX 2003. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM THE DEVICE AND THE COVER ON SUSPENSION ARM WAS CRACKED AND TAPED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. PREVIOUS D1 BRAND NAME HLX2004 CORRECTED D1 BRAND NAME HLX2004/HLX2003 PREVIOUS D4 VERSION OR MODEL # HLX 2000 - OTHER CORRECTED D4 VERSION OR MODEL # ARD56076864/ARD56076863. PREVIOUS D4 SERIAL # (B)(6). CORRECTED D4 SERIAL # (B)(6). GETINGE BECAME AWARE OF AN ISSUE WITH THE CONFIGURATION OF SURGICAL LIGHTS - HLX 2004 AND HXL2003. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM THE DEVICE AND THE COVER ON SUSPENSION ARM WAS CRACKED AND TAPED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION, DUE TO PAINT CHIPPING AND CRACKED COVER AND SUCH SCENARIO COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, OVER THE LAST 5 YEARS, THERE WAS NO SERIOUS INJURY OR WORSE REPORTED. A TECHNICAL EVALUATION OF PAINT CHIPPING AND PEELING WAS PERFORMED BY SUBJECT MATTER EXPERTS WHO STATED THE FOLLOWING. ALL MAQUET SAS PRODUCTS COMPLY WITH: IEC 60601-1 ED. 2.0 & ED. 3.0 GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE. 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 (56351039/E, PAGES 14 AND 9-10) 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 THE 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. ACCORDING TO THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, THE INCIDENT WITH SPRING ARM¿S COVER IS DUE TO INAPPROPRIATE USE. TO PREVENT SUCH AN ISSUE FROM REOCCURRING, THE MANUFACTURER¿S RECOMMENDATION IS TO FOLLOW THE INSTRUCTIONS FROM THE OPERATING MANUAL CONCERNING ARM PRE-POSITIONING PRIOR TO USE (IFU 56351039/E PAGES 9-10). ADDITIONALLY, USERS ARE REQUESTED TO PAY ATTENTION TO CRACKS IN PLASTIC PARTS (IFU 56351039/E PAGE 20). WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    ON 26TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE CONFIGURATION OF SURGICAL LIGHTS - HLX 2004 AND HXL2003. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM THE DEVICE AND THE COVER ON SUSPENSION ARM WAS CRACKED AND TAPED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE CONFIGURATION OF SURGICAL LIGHTS - HLX 2004. BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM THE DEVICE AND THE COVER ON SUSPENSION ARM WAS CRACKED AND TAPED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493962 HLX2004/HLX2003 LAMP, SURGICAL FTD MAQUET SAS ARD56076864/ARD56076863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown