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

Catalog Number ARD568370930

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue will be investigated by manufacturing site.

Event Description

On (b)(4) 2018 maquet (b)(4) became aware of a problem with one of surgical lights- powerled.As it was stated, the light detached from fork.There is no information about the circumstances of the event and the patient involvement however we decided to report the issue in abundance of caution.Manufacturer reference number #(b)(4).

Manufacturer Narrative

(b)(4).According to the information provided by technician who repaired the device, the bolts has broke and the light head detached.The circumstances of the issue are unknown.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.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).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.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption#: e2018005.(b)(6).Maquet sas became aware of an incident with a surgical light powerled device.As it was stated, the light detached from fork.There is no information about the circumstances of the event and the patient involvement however we decided to report the issue in abundance of caution.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.There is no information provided if the device was being used for patient treatment when the issue occurred.Despite many attempts to obtain more information related to the issue the originator of the complaint did not provide any.Therefore, after 5 why evaluation, we can assume that the issue is related to manufacturing-man mistake during manufacturing of the device.The retraining of employee will be proposed.We believe that this type of our devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature 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; orléans cedex 2 ; FR
• MDR Report Key: 7272898
• MDR Text Key: 100460155
• Report Number: 9710055-2018-00008
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568370930
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1