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

Model Number	ARDPWT639073A
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	10/22/2024
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
Getinge became aware of an issue with one of surgical equipment - eqt.It was stated the monitor box fell off during sugery, when nurse moved the monitor.There was no injury reported, however, we decided to report the issue in abundance of caution as monitor falling off during procedure may cause contamination of surgery tools or can cause serious injury to medical staff.
Additional Manufacturer Narrative
The correction of h4 manufacture date, d4 catalog #, unique identifier (udi) #, serial#, version or model #, b5 describe event and problem, d1 brand name, d2a and d2b product code., b5 describe event and problem deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2021-10-07 corrected h4 manufacture date: 2023-10-19 previous d1 brand name eqt corrected d1 brand name maquet powerled ii previous d2a product code.Fxr corrected d2a product code.Ftd previous d2b product code description.Holder, camera, surgical corrected d2b product code description.Lamp, surgical previous d4 catalog # ard567711940 corrected d4 catalog # blank previous d4 unique identifier (udi) #: n/a corrected d4 unique identifier (udi) #: (b)(4).Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous d4 version or model # ard567711940 corrected d4 version or model # ardpwt639073a previous b5 describe event and problem: getinge became aware of an issue with one of surgical equipment - eqt.It was stated the monitor box fell off during sugery, when nurse moved the monitor.There was no injury reported, however, we decided to report the issue in abundance of caution as monitor falling off during procedure may cause contamination of surgery tools or can cause serious injury to medical staff.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was stated the monitor box fell off during surgery, when nurse moved the monitor.There was no injury reported, however, we decided to report the issue in abundance of caution as monitor falling off during procedure may cause contamination of surgery tools or can cause serious injury to medical staff.Getinge became aware of an issue with one of surgical lights ¿ maquet powerled ii.It was stated the monitor box fell off during surgery, when nurse moved the monitor.There was no injury reported, however, we decided to report the issue in abundance of caution as monitor falling off during procedure may cause contamination of surgery tools or can cause serious injury to medical staff.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 claimed device was being used for patient treatment when the event took place.A root cause analysis was conducted by the subject matter expert.As stated: the rear box 01 may not have been secured properly during the installation or a maintenance.It can be considered as an isolated case.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
Getinge became aware of an issue with one of surgical lights ¿ powerled ii.It was stated the monitor box fell off during surgery, when nurse moved the monitor.There was no injury reported, however, we decided to report the issue in abundance of caution as monitor falling off during procedure may cause contamination of surgery tools or can cause serious injury to medical staff.

• 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: 20732933
• Report Number: 9710055-2024-0000597
• Device Sequence Number: 8370107
• Product Code: FTD
• UDI-Device Identifier: 03700712426279
• UDI-Public: (01)03700712426279
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: ARDPWT639073A
• Device Catalogue Number: ARD567711940
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown