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

Model Number	ARDPWT209009A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled ii 700.As it was stated, upon the preventive maintenance activities being performed on the device, the paint damage was identified.According to the photographic evidence, paint was chipping off from fork and keypad membrane was damaged with missing particles.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
Additional information will be provided following the conclusion of the investigation.Initial reporter: getinge service technician full event site name (e1): (b)(6).Gmbh h3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The correction of d1 brand name, d4 version of model #, d4 catalog #, 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.The correction of d4 catalog # deems required.This is based on the internal evaluation.Previous d1 brand name: powerled ii.Corrected d1 brand name: maquet powerled ii.Previous version of model # ard569201911.Corrected version of model # ardpwt209009a.Previous d4 catalog # ard569201911.Corrected d4 catalog # none.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 700.As it was stated, upon the preventive maintenance activities being performed on the device, the paint damage was identified.According to the photographic evidence, paint was chipping off from fork and keypad membrane was damaged with missing particles.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.The device has been repaired by replacement of pwdii-7-3 poles double fork kit (ard369224998) and returned to use.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.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).Additionally, this event is clearly due to the cleaning product.Nevertheless, the deterioration of the paint is far advanced and it must have started years ago.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.Such troubles should have been detected first by the user during daily and monthly checks.The current cleaning product must be improved as described in the user manual.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: 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: 17554784
• Report Number: 9710055-2023-00585
• Device Sequence Number: 19739572
• Product Code: FTD
• UDI-Device Identifier: 03700712407216
• UDI-Public: (01)03700712407216
• 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): 08/16/2023

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: ARDPWT209009A
• Device Catalogue Number: ARD569201911
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown