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

Model Number	ARDPWT229061A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2nd january, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.As it was stated, the covers were broken with missing particles due to physical damage, probably rear covers from spring arms.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 in case of reoccurrence.
Additional Manufacturer Narrative
Event site name: (b)(6) health svcs dist.Contact person name: (b)(6).Event site telephone: (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
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Initial reporter was hospital maintenance worker.The correction of d4 version or model#, d4 catalog#, h4 manufacture date, 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 d4 version or model#: ard569201907.Corrected d4 version or model#: ardpwt229061a.Previous d4 catalog#: ard569201907.Corrected d4 catalog#: blank.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.Previous h4 manufacture date: 2019-12-12.Corrected h4 manufacture date: 2019-12-17.Getinge became aware of an issue with one of surgical lights - powerled ii 700.As it was stated, the covers were broken with missing particles due to physical damage, probably rear covers from spring arms.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 in case of reoccurrence.The device has been repaired by replacement of pwdii-7-upper cover + handle (ard369221998) and returned to use.Based on the information collected, 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.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.A root cause analysis was performed by subject matter experts, and it was established that the cause of this damage is probably a mechanical shock.To prevent any incidents, the instruction for use ifu 01811 operating instructions mentions: "the use of a damaged device may lead to a risk of injury for users or a risk of infection for patients.Do not use a damaged device." "check that the device has not suffered any impact damage." 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 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: 18562491
• Report Number: 9710055-2024-00073
• Device Sequence Number: 6660322
• Product Code: FTD
• UDI-Device Identifier: 03700712411398
• UDI-Public: (01)03700712411398
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 01/23/2024

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
• Device Model Number: ARDPWT229061A
• Device Catalogue Number: ARD569201907
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown