MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2005; LIGHT, SURGICAL, CEILING MOUNTED

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.(b)(4).Device not returned to teh manufacturer.

Event Description

On (b)(6) 2019 maquet sas became aware about an issue with one of the surgical light- hanaulux 2005.As it was stated in the user report sent to bfarm, at the beginning of an operation the surgical light showed a malfunction.When surgical assistant was checking the lamp, the light detached itself from the spring arm and fell into the ground, hitting surgical assistant's head, shoulders and back.Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(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

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 about an issue with one of the surgical light- hanaulux 2005.As it was stated in the user report sent to bfarm, at the beginning of an operation the surgical light showed a malfunction.When surgical assistant was checking the lamp, the light detached itself from the spring arm and fell onto the ground, hitting surgical assistant's head, shoulders and back.There was no information provided about the injury sustained.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 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: HANAULUX 2005
• 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: 8686279
• MDR Text Key: 147886210
• Report Number: 9710055-2019-00195
• 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: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other