BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED 700

    MDR report key: 18310100 · Received December 12, 2023

    Report

    Report Number
    9710055-2023-00951
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 29, 2023
    Report Date
    December 12, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE ABRASION PARTICLES CAME OFF FROM THE CONNECTION OF SUSPENSION ARM AND SPRING ARM DUE TO COLLISION WITH THE SECOND LAMP ARM. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF REOCCURRENCE. ACCORDING TO THE INFORMATION FROM THE TECHNICIAN DEFECT OCCURRED DUE TO COLLISION WITH OTHER LAMP, AND DEFECTIVE PART (HM56053311 KOM-BLUE 90/130/100 F-ARM ABDECKBL. 4ST.) WAS REPLACED, THEN DEVICE RETURNED TO USAGE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION, DUE TO PAINT PEELING, WHICH COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE, IF THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT WHILE ISSUE OCCURRED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, IT WAS CONFIRMED THAT IN THE LAST 5 YEARS, REGISTERED FOR THE ISSUE OF PAINT PEELING ON POWERLED AND HLED SURGICAL LIGHTS, THERE IS ONE EVENT WHICH LED TO THE SERIOUS INJURY. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO OF THE PAINT CHIPPING IS MODERATE. A ROOT CAUSE ANALYSIS FOR PAINT PEELING PROBLEM WAS PERFORMED BY SUBJECT MATTER EXPERTS AND CONCLUDED THAT 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 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 DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON 29TH NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE ABRASION PARTICLES CAME OFF FROM THE CONNECTION OF SUSPENSION ARM AND SPRING ARM DUE TO COLLISION WITH THE SECOND LAMP ARM. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION IN CASE OF REOCCURRENCE.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111162 POWERLED 700 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568370936

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown