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

Model Number	ARDPWT229003A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1: event site postal code: (b)(4).
Event or Problem Description
On 20th june 2024 getinge became aware of an issue with configuration of one of our surgical lights ¿ powerled ii.As it was stated, outer seals were missing from all 3 headlights on this device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.
Additional Manufacturer Narrative
Getinge became aware of an issue with configuration of one of our surgical lights ¿ powerled ii.As it was stated, outer seals were missing from all 3 headlights on this device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.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.It was detected a missing peripheral seal on a powerled ii 500 light head.The cause is unknown, no more detail was provided.A new peripheral seal was installed and the device returned to service.To prevent any incident the powerled ii instruction for use ¿ifu 01811¿ mentions: ¿the product must not be modified in any way without the prior written consent of getinge¿, ¿check that the lighthead gaskets are in the proper position and in good condition¿.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.The correction of d4 catalog#, version or model#, unique identifier (udi)# deems required.This is based on the internal evaluation.Previous d4 catalog#: ard569202915, corrected d4 catalog#: blank, previous d4 version or model#: ard569202915, corrected d4 version or model#: ardpwt229003a, previous d4 unique identifier (udi)#: n/a, corrected d4 unique identifier (udi)#: (b)(4).The correction of d1 brand name deems required.This is based on the internal evaluation.Previous d1: brand name powerled ii, corrected d1: brand name maquet powerled ii.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• 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: 19769547
• Report Number: 9710055-2024-00425
• Device Sequence Number: 8777993
• Product Code: FTD
• UDI-Device Identifier: 03700712408084
• UDI-Public: (01)03700712408084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: ARDPWT229003A
• Device Catalogue Number: ARD569202915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown