MAUDE Adverse Event Report: MAQUET SAS MAQUET POWERLED II; LAMP, SURGICAL

Model Number	ARDPWT239222A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1b event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 5th april, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 500.Based on photographic evidence the designated complaint unit employee found that paint was chipping from headlight and label was chipping from fork with risk of missing particles.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.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The correction of d1 brand name, d4 catalog #, d4 version or model #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer?, h3b device not eval provide code and h3c if other provide code -explain fields deems required.This is based on the internal evaluation.Previous d1 brand name: powerled ii 500; corrected d1 brand name: maquet powerled ii; previous d4 version or model #: ard569202911; corrected d4 version or model #: ardpwt239222a; previous d4 catalog #: ard569202911; corrected d4 catalog #: blank; previous d4 unique identifier (udi) #: n/a; corrected d4 unique identifier (udi) #: (b)(4); 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 ii 500.Based on photographic evidence the designated complaint unit employee found that paint was chipping from headlight and label was chipping from fork with risk of missing particles.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.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.There is no information if the claimed device was not being used for patient treatment or diagnosis when the event took place.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.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 cover of lighthead was cracked: the cause of this damage is probably a mechanical shock.To prevent any incidents, the instruction for use ifu 01811 operating instructions mentions: "the use of a damaged device may lead to a risk of injury for users or a risk of infection for patients.Do not use a damaged device." "check that the device has not suffered any impact damage." getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: MAQUET POWERLED II
• Common Device Name: LAMP, SURGICAL
• 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: 19124909
• Report Number: 9710055-2024-00284
• Device Sequence Number: 12851831
• Product Code: FTD
• UDI-Device Identifier: 03700712410216
• UDI-Public: (01)03700712410216
• 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): 04/17/2024

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: ARDPWT239222A
• Device Catalogue Number: ARD569202911
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown