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

Model Number ARD567911211C

Device Problems Detachment of Device or Device Component (2907); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of our surgical light ¿ blue.As it was stated by the customer during the procedure part of the device has fallen down and additionally deformation of the device occurred due to overheating of the device.No injury was reported due to mentioned issue, however we decided to report this case in abundance of caution as any parts falling down might cause contamination or led to serious injury.

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light ¿ blue.As it was stated by the customer during the procedure part of the device has fallen down and additionally deformation of the device occurred due to overheating of the device.No injury was reported due to mentioned issue, however we decided to report this case in abundance of caution as any parts falling down might cause contamination or led to serious injury.It was established that when the issue occurred, the light head did not meet its specification and it contributed to the complaint as the cover shouldn¿t deform.In the time when the issue occurred the device was being used for patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand and that the reported malfunction has never lead to serious injury or worse.We conclude that the issue is most likely caused by wrong maintenance of the device.This defect is visually detectable during the inspection performed by the users before any surgical procedure.Moreover, the bulb of the customer is different from the maquet bulb and has non-conforming technical specifications.An inappropriate bulb could damage the medical device.We believe the related devices are performing correctly in the market.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: BLUELINE
• 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: 9744079
• MDR Text Key: 183092543
• Report Number: 9710055-2020-00025
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD567911211C
• Device Catalogue Number: ARD567911211C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1