MAUDE Adverse Event Report: MAQUET SAS BLUE 80; LIGHT, SURGICAL, FLOOR STANDING

Catalog Number 569051999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 getinge became aware of an issue with one of surgical lights - blue 80.As it was stated, the locking screw was missing on the spring arm.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure could be a source of contamination.

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On (b)(6) 2018 getinge became aware of an issue with one of surgical lights - blue 80.As it was stated, the torx screw was missing on the spring arm what led to detachment of the lighthead.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure could be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that evaluated case has not led to serious injury nor death.It is indicated by our product experts that the headlight¿s detachment occurred due to omission of following the correct preventive maintenance (related to verification of the correct fitment of the screw).We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: BLUE 80
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9416255
• MDR Text Key: 178203079
• Report Number: 9710055-2019-00344
• Device Sequence Number: 1
• Product Code: FSS
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 569051999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1