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

Model Number	ARD568446512A
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	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 29th november 2023 getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the ambient light detached and fell down during case and as a result procedure was interrupted or delayed.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or 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.E1b event site name: (b)(6) medical center.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 29th november 2023 getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the ambient light detached and fell onto medication cart during case and as a result procedure was interrupted or delayed.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
The correction of b5 describe event and problem , d1 brand name, d4 version of model #, d4 catalog # , d4 unique identifier (udi) #, h4 manufacture date deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 29th november 2023 getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the ambient light detached and fell down during case and as a result procedure was interrupted or delayed.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 29th november 2023 getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the ambient light detached and fell onto medication cart during case and as a result procedure was interrupted or delayed.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Previous d1 brand name: powerled 700.Corrected d1 brand name: powerled tm.Previous d4 version of model # ard568371938.Corrected d4 version of model # ard568446512a.Previous d4 catalog # ard568371938.Corrected d4 catalog # none.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h4 manufacture date: 2018-10-29.Corrected h4 manufacture date: 2018-10-30.Getinge became aware of an issue with one of surgical lights - powerled 700.As it was stated, the ambient light detached and fell onto medication cart during case and as a result procedure was interrupted or delayed.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or 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 being used for patient treatment or diagnosis when the event took place.The detachment of the ambient module was caused by a collision or an excessive strain during the cleaning.The user manual mentions to perform daily inspections checking that the device has not suffered any impact and any other damage.The pwd-hled light head must be used according to the instructions for use.To prevent any degradation, it is recommended to avoid collisions and to wipe the surfaces with a moderate effort and with a dry cloth to make sure that no liquid residue is left on the device after cleaning.Getinge shall continue to monitor for any further events of this nature and does 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: 18308415
• Report Number: 9710055-2023-00945
• Device Sequence Number: 6784272
• Product Code: FSY
• UDI-Device Identifier: 03700712401931
• UDI-Public: (01)03700712401931
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/12/2023

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: ARD568446512A
• Device Catalogue Number: ARD568371938
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown