MAUDE Adverse Event Report: MAQUET SAS POWERLED TM; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARD568425010A
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 31st july, 2024 getinge became aware of an issue with one of surgical lights - powerled.During preventive maintenance by getinge, the paint damage (chipped paint) was found on the entire lighting system.In addition, the fastening screws for the covers were missing on a spring arm.The designated complaint unit employee confirmed based on photographic evidence the paint was chipping form headlight handle, suspension arm and spring arm and fork, the labels were torn with missing particles and the screws and caps were missing from spring arm.We decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.
Event or Problem Description
On 31st july, 2024 getinge became aware of an issue with one of surgical lights - powerled.During preventive maintenance by getinge, the paint damage (chipped paint) was found on the entire lighting system.In addition, the fastening screws for the covers were missing on a spring arm and keypad membrane was damaged with missing particles.The designated complaint unit employee confirmed based on photographic evidence the paint was chipping form headlight handle, suspension arm and spring arm and fork, the labels were torn with missing particles and the screws and caps were missing from spring arm.We decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, d1 brand name, d4 unique identifier (udi) #, d4 catalog #, h6 component codes: fields deems required.This is based on the internal evaluation.; previous b5 describe event and problem: on 31st july, 2024 getinge became aware of an issue with one of surgical lights - powerled.During preventive maintenance by getinge, the paint damage (chipped paint) was found on the entire lighting system.In addition, the fastening screws for the covers were missing on a spring arm.The designated complaint unit employee confirmed based on photographic evidence the paint was chipping form headlight handle, suspension arm and spring arm and fork, the labels were torn with missing particles and the screws and caps were missing from spring arm.We decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.; corrected b5 describe event and problem: on 31st july, 2024 getinge became aware of an issue with one of surgical lights - powerled.During preventive maintenance by getinge, the paint damage (chipped paint) was found on the entire lighting system.In addition, the fastening screws for the covers were missing on a spring arm and keypad membrane was damaged with missing particles.The designated complaint unit employee confirmed based on photographic evidence the paint was chipping form headlight handle, suspension arm and spring arm and fork, the labels were torn with missing particles and the screws and caps were missing from spring arm.We decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.; previous d1 brand name: powerled; corrected d1 brand name: powerled tm; previous d4 unique identifier (udi) #: n/a; corrected d4 unique identifier (udi) #: (01)03700712402563(11)180704(21)500073; previous d4 catalog #: ard568425010a; corrected d4 catalog #: blank; previous h6 component codes: mechanical|coating material||4768, mechanical|cap||424, mechanical|label||862, mechanical|fastener|screw|568; corrected h6 component codes: mechanical|coating material||4768, mechanical|cap||424,mechanical|label||862, mechanical|fastener|screw|568, mechanical|membrane||484; getinge became aware of an issue with one of surgical lights - powerled.During preventive maintenance by getinge, the paint damage (chipped paint) was found on the entire lighting system.In addition, the fastening screws for the covers were missing on a spring arm and keypad membrane was damaged with missing particles.The designated complaint unit employee confirmed based on photographic evidence the paint was chipping form headlight handle, suspension arm and spring arm and fork, the labels were torn with missing particles and the screws and caps were missing from spring arm.We decided to report the issue in abundance of caution as any rust particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.The claimed device was not being used for patient treatment or diagnosis when the event took place.The possible root causes for missing cover are: - non-conformity of the metal covers assembly.- degradation of the metal covers.- improper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.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 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 pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.The keypad peeling off is a normal wear at this location.In the chapter daily inpections before use the user manual mentions to check that the keypad is in good condition.As soon as a default is noticed on the keypad membrane, its replacement must be performed.The film protection is available as spare part.Label peeling 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.The fact that one cover screw was found sheared couldn¿t lead to the cover fall because it was still held by the remaining screw and also by all the clips.Indeed, the spring arm cover sides are attached to each other by 8 clips.This kind of breakage cannot occur during use because no stress is applied at this location.The most likely root cause is an excessive tightening during maintenance or installation.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: POWERLED TM
• 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: 19916161
• Report Number: 9710055-2024-00463
• Device Sequence Number: 7207642
• Product Code: FSY
• UDI-Device Identifier: 03700712402563
• UDI-Public: (01)03700712402563(11)180704
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K070442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: ARD568425010A
• Device Catalogue Number: ARD568425010A
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown