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

Model Number ARDPWT259215A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with powered ii surgical light.As it was stated, safety clips were missing.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 could lead to contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number (b)(4).

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with powerled ii surgical light.As it was stated, safety clips were missing.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 could lead to contamination.During investigation, it was found that device was not according to the manufacturer¿s specification as clips shouldn¿t be missing.There is no information if in the time when the event occurred, the device was or was not being used for patient treatment and it contributed to the event.The safety spring assembly was most likely forgotten during installation.The spring is a dual safety design, there is no risk of falling because the safety collar covers the safety segment and prevents its removal.Moreover, the straight pin crosses the collar and the axle pin avoiding any detachment.To prevent any safety issue the user and installation manual ot54 & ot94 rev.: sss05o11 mavig #5100030 shows the position of the safety components on the technical drawing and mentions how to install them.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: POWERLED II
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11540962
• MDR Text Key: 241418492
• Report Number: 9710055-2021-00105
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDPWT259215A
• Device Catalogue Number: ARDPWT259215A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2021
• Patient Sequence Number: 1