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

Model Number	ARDPWT229097A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On 29th january, 2024 getinge became aware of an issue with one of surgical lights - powerled ii.Based on photographic evidence the designated complaint unit employee found that the keypad membrane was cracked with 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 or serious injury.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of h4 manufacture date, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields, d4 catalog # and unique identifier (udi) #, d1 brand name deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2021-12-24.Corrected h4 manufacture date: 2021-12-27.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.Previous d4 catalog # ard569201963.Corrected d4 catalog # blank.Previous d4 version or model # ard2pwt00040a.Corrected d4 version or model # ardpwt229097a.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous d1 brand name powerled ii.Corrected d1 brand name maquet powerled ii.Getinge became aware of an issue with one of surgical lights - powerled ii.Based on photographic evidence the designated complaint unit employee found that the keypad membrane was cracked with 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 or serious injury.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.There is no information if the claimed device was being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed.As stated by the subject matter expert, the photographic evidence shows several light impacts and scratches on the protective layer of the keypad, these damages are located on the perimeter and inside the keypad surface.The cause is probably collisions with other equipment.To prevent any incident the powerled ii instructions for use mentions to check that the device has not suffered any impact damage and to check for any chipped or cracked during the daily inspections before use.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: 18622290
• Report Number: 9710055-2024-00111
• Device Sequence Number: 16745586
• Product Code: FTD
• UDI-Device Identifier: 03700712411763
• UDI-Public: (01)03700712411763
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: ARDPWT229097A
• Device Catalogue Number: ARD569201963
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown