MAUDE Adverse Event Report: MAQUET SAS POWERLED 300/500; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARD568420752A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled 300/500.Based on photographic evidence the label and the paint were chipping from the forks.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.The initial reporter was getinge technician.Event site name: (b)(6).Event site telephone:(b)(6).H3: device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d4 version or model # deems required.This is based on the internal evaluation.Previous d4 version or model # ard568350933/ard568330933.Corrected d4 version or model # ard568420752a.Getinge became aware of an issue with one of surgical lights - powerled 300/500.Based on photographic evidence the label and the paint were chipping from the forks.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 gathered, a service overview for the repair was presented by getinge employee, however customer decided to reject it.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 and label chipping off which could be considered as technical deficiencies, and in this way the device contributed to the event.Provided information indicate 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 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.As for the other malfunction investigated herein it was confirmed that there was no event in the last 5 years which led to 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 and for chipped or missing label is low.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.¿ 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_01581en09_extract, 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 the collisions between devices.Visual inspections during the cleaning allow to detect the impacts, it is recommended 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.Regarding the label peeling, as concluded by subject matter experts at maquet sas, the issue is probably due to collision or repeated excessive rubbing during cleaning of the device, the use of aggressive or unsuitable cleaning agents may be a contributing factor.The user manual mentions to check the lightheads for chipped paint, impact marks and any other damages during daily checks devices (powerled_01581en09_extract, pages 20-22).Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED 300/500
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 17029221
• Report Number: 9710055-2023-00406
• Device Sequence Number: 6413094
• Product Code: FSY
• UDI-Device Identifier: 03700712402174
• UDI-Public: (01)03700712402174
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568420752A
• Device Catalogue Number: ARD568350933/ARD568330933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown