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

Model Number	ARDPWT259055A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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
On 11th october 2023, getinge became aware of an issue with one of surgical lights - powerled ii 700.As it was stated, two screws holding the device main tube were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as missing screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Initial reporter was getinge technician.; the correction of d1 brand name, d4 version or model #, d4 catalog #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer?, h3b device not eval provide code and h3c if other provide code -explain fields deems required.This is based on the internal evaluation.; previous d1 brand name: powerled ii; corrected d1 brand name: maquet powerled ii; previous d4 version or model #: ard569241917; corrected d4 version or model #: ardpwt259055a; previous d4 catalog #: ard569241917; corrected d4 catalog #: blank; previous d4 unique identifier (udi) #: n/a; corrected d4 unique identifier (udi) #: (b)(4); 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 ii 700.As it was stated, two screws holding the device main tube were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as missing screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.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 not being used for patient treatment or diagnosis when the event took place.According to the information collected, these screws were probably forgotten during installation.The powerledii installation manual 01814 mentions: - using a 5 mm allen key, tighten the six screws; - use a torque wrench to finish tightening to a torque of 16 n.M.To prevent any incident, it is recommended to follow the instruction included in the powerledii installation manual 01814.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: 17938276
• Report Number: 9710055-2023-00762
• Device Sequence Number: 6795620
• Product Code: FTD
• UDI-Device Identifier: 03700712416362
• UDI-Public: (01)03700712416362
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/16/2023

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: ARDPWT259055A
• Device Catalogue Number: ARD569241917
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown