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

Model Number	ARDPWT229003A
Medical Device Problem Code	Peeled/Delaminated (1454)
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: device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the label was chipping off.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The initial reporter was in-house medical technician.The correction of b5 describe event and problem, d4 version or model, d4 catalog #, d4 serial #, 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 b5 describe event and problem: on 16th june, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the label was chipping off.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or duridng procedure may cause contamination.Corrected b5 describe event and problem: on 12th june, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the label was chipping off.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Previous d4 version or model #: ard569202915.Corrected d4 version or model #: ardpwt229003a.Previous d4 catalog #: ard569202915.Corrected d4 catalog #: blank.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).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 our surgical lights ¿ powerled ii.As it was stated the label was chipping off.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.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 most probable root cause of torn label is an excessive friction during cleaning.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
On 12th june, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled ii.As it was stated the label was chipping off.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: 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: 17197317
• Report Number: 9710055-2023-00469
• Device Sequence Number: 12204406
• Product Code: FTD
• UDI-Device Identifier: 03700712408084
• UDI-Public: (01)03700712408084
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: ARDPWT229003A
• Device Catalogue Number: ARD569202915
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown