MAUDE Adverse Event Report: MAQUET SAS POWERLED TM; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARD568420512A
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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 13th august, 2024 getinge became aware of an issue with one of surgical lights - powerled.It was stated the piece was missing from the boom.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 h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.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.It was stated the piece was missing from the boom.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 claimed device was or was not being used for patient treatment or diagnosis when the event took place.As stated by subject matter expert at the manufacturing site, maquet sas did not receive enough information to conduct the technical investigation.It is therefore not possible to determine the root cause nor provide the most probable root causes.In case of new relevant information, the case will be reconsidered.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED TM
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 20037036
• Report Number: 9710055-2024-00481
• Device Sequence Number: 6537083
• Product Code: FSY
• UDI-Device Identifier: 03700712402143
• UDI-Public: (01)03700712402143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070442
• 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): 08/22/2024

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: ARD568420512A
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown