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

Catalog Number HM56077460

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 getinge became aware of an issue with one of examination lights ¿ blueline 30s.As it was stated by the customer, the bulb shattered and protective screen was damaged.As a result, the glass parts fell off to the ground.There was no injury reported however we decided to report the issue based on the potential as any particles falling off might cause a contamination.

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with an examination light ¿ blueline 30s.As it was stated by the customer, the bulb shattered and protective screen was damaged.As a result, the glass parts fell off to the ground.There was no injury reported however we decided to report the issue based on the potential as any particles falling off might cause a contamination.It was established that when the event occurred, apart from the obvious failure taking place, possibly due to the age and lifetime of use, the surgical light did meet its specification.None of information available to date suggest that at the time when the event occurred the device was being used for the patient treatment.During the investigation, it was found that the reported scenario has never lead, to date, to serious injury or worse.The explosion of the halogen bulb can be caused by: a wear of the filament due to the excess of recommended replacement cycle.A weakness of the bulb caused by foreign particles.A power supply parameter non-compliance.It is worth to be noted that the manufacturing date is 6th december, 2006 which means that device was in use for 13 years since malfunction occurred.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

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

• Brand Name: BLUELINE
• 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: 9103794
• MDR Text Key: 175199424
• Report Number: 9710055-2019-00273
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HM56077460
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1