MAUDE Adverse Event Report: MAQUET SAS POWERLED II 700; LAMP, SURGICAL

Model Number	ARDPWT259052A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On (b)(6) 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled ii 700.As it was stated the top cover was cracked and it was breaking into small pieces of plastic which have the potential to fall.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.
Additional Manufacturer Narrative
The correction of d4 version or model #, catalog #, h3b device not eval provide code fields deems required.This is based on the internal evaluation.The correction of d4 version or model # and d4 catalog # deems required.This is based on the internal evaluation.Previous d4 version or model #: ard569201917 corrected d4 version or model #: ardpwt259052a previous d4 catalog #: ard569201917 corrected d4 catalog #: blank previous h3b device not eval provide code: device evaluation anticipated, but not yet begun corrected h3b device not eval provide code: blank getinge became aware of an issue with one of our surgical lights ¿ powerled ii 700.As it was stated the top cover was cracked and it was breaking into small pieces of plastic which have the potential to fall.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.Based on an information gathered, defective pwdii-7-upper cover + handle (ard369221998) was replaced and the device was released for clinical use.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.The device was not being used for patient treatment upon the event occurrence.According to the information gathered, the issue was discovered during cleaning.Root cause analysis was performed by subject matter expert at the manufacturer.As they stated, the light must have received not minor shocks but violent shocks and impacts (misuse) with probably another devices.This cover breakage is the result of collisions and misuse.Or equipment is colliding directly with the cover of the light.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: POWERLED II 700
• 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: 19257916
• Report Number: 9710055-2024-00314
• Device Sequence Number: 2582342
• Product Code: FTD
• UDI-Device Identifier: 03700712416379
• UDI-Public: (01)03700712416379
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/07/2024

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: ARDPWT259052A
• Device Catalogue Number: ARD569201917
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown