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

Model Number ARD569051999

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 05/13/2021

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 blueline surgical light.The headlight's cover has cracked, leading to missing plastic particles, what was confirmed by a photographic evidence.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.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with blueline surgical light.The headlight's cover has cracked, leading to missing plastic particles, what was confirmed by a photographic evidence.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.It was established that when the event occurred, the surgical light did not meet its specification, since appearance of cracked cover could be considered as technical deficiency, and in this way device contributed to event.We have not received information whether the device was being used for patient treatment at the time when the event occurred.According to the customer himself this incident is the result of a misuse and this is the root cause of the light head missing particles.Service technician was informed that: "biomedical engineering personnel informed me that the damage is the result of the patient pavilion users moving the light in such a way as to lead to collisions with the bottom of the ceiling suspension¿.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.

• 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: 11869946
• MDR Text Key: 252171309
• Report Number: 9710055-2021-00198
• 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: 07/02/2021

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: ARD569051999
• Device Catalogue Number: ARD569051999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/02/2021
• Patient Sequence Number: 1