BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 15885146 · Received November 30, 2022

    Report

    Report Number
    9710055-2022-00495
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 29, 2022
    Report Date
    November 30, 2022
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE PAINT WAS CHIPPING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE CUSTOMER RECEIVED A QUOTE FOR A REPAIR, HOWEVER, IT HAS NOT BEEN ACCEPTED. 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 INDICATES THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. THE ISSUE WAS DETECTED BY GETINGE TECHNICIAN DURING PERFORMING THE MAINTENANCE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS 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 (POWERLED¿S INSTRUCTIONS FOR USE 01581 REV. 9, PAGE 27) 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 (POWERLED¿S IFU 01581 REV. 9, PAGE 27). 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. FOR THE TYPE OF CASE AT HAND THE SUBJECT MATTER EXPERT ALSO INDICATES AS FOLLOWS: THIS EVENT IS CLEARLY DUE TO THE CLEANING PRODUCT. NEVERTHELESS, THE DETERIORATION OF THE PAINT IS FAR ADVANCED AND IT MUST HAVE STARTED YEARS AGO. SUCH TROUBLES SHOULD HAVE BEEN DETECTED FIRST BY THE USER DURING DAILY AND MONTHLY CHECKS. THE CURRENT CLEANING PRODUCT MUST BE IMPROVED AS DESCRIBED IN THE USER MANUAL. THE DAMAGED PARTS MUST BE REPLACED AS SOON AS POSSIBLE. USER MANUAL FOR POWERLED MENTIONS THE RECOMMENDATIONS ABOUT DAILY INSPECTION, PROPER CLEANING METHODOLOGY AND PREVENTIVE MAINTENANCE. 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. THE CORRECTION OF D4 CATALOG # AND D4 SERIAL # FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG # ARD568412010C CORRECTED D4 CATALOG # ARD568350900/ARD568350902 PREVIOUS D4 SERIAL # (B)(6) CORRECTED D4 SERIAL # (B)(6).

    Description of Event or Problem · 0

    ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE PAINT WAS CHIPPING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330498 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568412010C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown