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

Model Number ARD568370900

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2021

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 the issue with powerled surgical light.As it was stated by the customer, the surgical light broke at one of the joints and the light head was removed.There was no injury reported, however we decided to report the issue in abundance of caution as this kind of malfunction could lead to detachment of light head and then to serious injury.

Manufacturer Narrative

Getinge became aware of the issue with powerled surgical light.As it was stated by the customer, the surgical light broke at one of the joints and the light head was removed.There was no injury reported, however we decided to report the issue in abundance of caution as this kind of malfunction could lead to detachment of light head and then to serious injury.Technician has replaced the fork on the light head and unit was returned to usage.It was established that when the event occurred, the surgical light did not meet its specification as connection between fork and headlight was loose and it contributed to event.We have not received information whether the device was being used for patient treatment at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.The gap between the fork and the light head was caused by a loosening of the bracket fixing screws over a long period of time due to a lack of thread-locking patch on 3 screws in production line (isolated case).To prevent any safety issue the user manual mentions to check the light heads for chipped paint, impact marks and any other damage and to perform yearly preventive maintenance.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior of this nature, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: POWERLED
• 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: 11372214
• MDR Text Key: 233273424
• Report Number: 9710055-2021-00074
• 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
• Report Date: 03/26/2021

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 Operator: Health Professional
• Device Model Number: ARD568370900
• Device Catalogue Number: ARD568370900
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1