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

Catalog Number ARD222201010A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of incident with one of the surgical lamp- powerled 500.As it was stated, the light body dropped from the spring arm and hit a professional healthcare worker at a shoulder causing injury described as ¿small¿.No more information regarding the injury sustained was provided.The issue was decided to be reportable to competent authorities.

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

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer's 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 incident with one of the surgical lamp- powerled 500.As it was stated, the light body dropped from the spring arm and hit a professional healthcare worker at a shoulder causing injury described as ¿small¿.No more information regarding the injury sustained was provided.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: POWERLED
• 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: 8711504
• MDR Text Key: 148415378
• Report Number: 9710055-2019-00204
• 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,Followup,Followup,Followup
• Report Date: 12/12/2019

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: No Information
• Device Catalogue Number: ARD222201010A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/14/2019; 06/14/2019; 06/14/2019; 06/14/2019; 06/14/2019; 06/14/2019; 11/26/2019
• Supplement Dates FDA Received: 07/12/2019; 08/06/2019; 08/30/2019; 09/24/2019; 10/18/2019; 11/15/2019; 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other