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

Model Number ARD568520010C - CEILING MOUNTED (55, 73) MEDIUM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Headache (1880)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6), 2019 getinge became aware of an issue with one of surgical lights- hled.As it was stated, the surgical light suddenly fell down and hit surgeon's head.Information provided does not suggest, that surgeon required medical intervention.

Manufacturer Narrative

The issue is still 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

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 one of surgical lights- hled.As it was stated, the surgical light suddenly fell down and hit the surgeon¿s head.It was established that he felt pain for some minutes and no medical intervention was required.Moreover, the issue occurred during the movement of the cupola to the proper position before surgery and patient was not on the table at the moment when the issue occurred.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.In the time when the event occurred the device was not being used for the patient treatment.Upon the performed investigation it was established that the event occurred as a combination of three different factors: a missing screw, the vertical motion of the safety sleeve and the transition of the safety segment.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.Given the circumstances and the fact that the occurrence rate is considered to be low we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: HLED
• 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: 8953593
• MDR Text Key: 174932572
• Report Number: 9710055-2019-00267
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568520010C - CEILING MOUNTED (55, 73) MEDIUM
• Device Catalogue Number: ARD568520010C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/02/2019
• Supplement Dates Manufacturer Received: 08/15/2019; 08/15/2019; 11/20/2019; 01/23/2020
• Supplement Dates FDA Received: 09/27/2019; 10/22/2019; 11/20/2019; 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other