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

Model Number	ARDPWT229061A
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	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 17th june, 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the unit had physical damage with missing particles to cover due to collision.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
Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the unit had physical damage with missing particles to cover due to collision.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, 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.It is unknown if the claimed device was being used for patient treatment or diagnosis when the event took place.According to the information provided, the damages detected on the light head cover were caused by a collision.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 #, d4 version or model # and unique identifier (udi) # deems required.This is based on the internal evaluation.Previous d4 catalog # ard569201907.Corrected d4 catalog # blank.Previous d4 version or model # ard569201907.Corrected d4 version or model # ardpwt229061a.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).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the unit had physical damage with missing particles to cover due to collision.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, 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.It is unknown if the claimed device was being used for patient treatment or diagnosis when the event took place.According to the information provided, the damages detected on the light head cover were caused by a collision.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 #, d4 version or model # and unique identifier (udi) # deems required.This is based on the internal evaluation.Previous d4 catalog # ard569201907.Corrected d4 catalog # blank.Previous d4 version or model # ard569201907.Corrected d4 version or model # ardpwt229061a.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: 19759036
• Report Number: 9710055-2024-00420
• Device Sequence Number: 18361466
• Product Code: FTD
• UDI-Device Identifier: 03700712411398
• UDI-Public: (01)03700712411398
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: ARDPWT229061A
• Device Catalogue Number: ARD569201907
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown