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

Model Number	ARDPWD209012A
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	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 27th february, 2024 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the rear cover was about to come off.We decided to report the issue in abundance of caution as considering the worse case scenario the cover could detach from the device and fall off into the sterile field, therefore it might be a source of contamination or serious injury.
Additional Manufacturer Narrative
The correction of h4 manufacture date, d4 catalog #, d1 brand name, h3a device evaluated by manufacturer?, h3b device not eval provide code and h3c if other provide code -explain deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2016-09-28.Corrected h4 manufacture date: 2016-09-29.Previous d4 catalog #: ard568350933.Corrected d4 catalog #: blank.Previous d1 brand name: powerled.Corrected d1 brand name: powerled tm.Previous d4 version of model #: ard568350933.Corrected d4 version of model #: ardpwd209012a.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 500.It was stated the rear cover was about to come off.We decided to report the issue in abundance of caution as considering the worse case scenario the cover could detach from the device and fall off into the sterile field, therefore it might be a source of 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.There is no information if the claimed device was not being used for patient treatment or diagnosis when the event took place.The fall of plastic cover is due to an incorrect attachment of the dust cover or a detachment due to repeated collisions.The collision of the spring arms occurred during the handling of the device.The incident is due to an inappropriate use.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.Additionally, the users are requested to pay attention to cracks in plastic parts.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
Manufacturer's reference number (b)(4).

• 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: 18854365
• Report Number: 9710055-2024-00197
• Device Sequence Number: 20892779
• Product Code: FSY
• UDI-Device Identifier: 03700712403461
• UDI-Public: (01)03700712403461
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070442
• 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): 03/07/2024

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: ARDPWD209012A
• Device Catalogue Number: ARD568350933
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown