MAUDE Adverse Event Report: MAQUET SAS X-TEN; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD567801999

Device Problem Activation Failure (3270)

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

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 25th of april getinge became aware of and incident with x-ten surgical light.It was reported by the customer that the light turned off during the procedure.The patient was transferred to another operating room and the medical procedure was completed.There was no injury reported as a result of this event, however, we have decided to report it due to potential risk, as in case of reoccurrence, for instance during life saving surgery, the issue could lead to serious injury or worse.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

It was established that when the event occurred, the surgical light failed to meet its specification, due to malfunction of bulb holder and it contributed to the event.The device was being used for patient treatment at the time when the event occurred.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.The manufacturing site performed an investigation.Subject matter expert decided that this issue is due to lack of maintenance.The light switched off due to a bulb wear.To prevent this type of incident the x-ten user manual mentions to check the bulb daily, and to replace the bulb every year or every 600 to 800 hours.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

• Brand Name: X-TEN
• 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: 11797386
• MDR Text Key: 249778535
• Report Number: 9710055-2021-00171
• 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
• Report Date: 10/14/2021

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: ARD567801999
• Device Catalogue Number: ARD567801999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/25/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/14/2021
• Patient Sequence Number: 1