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

Catalog Number ARD568811950

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The issue is being investigated by manufacturing site.

Event Description

On (b)(6) 2018 (b)(4) became aware of an incident with one of surgical lights- volista.As it was stated, the light turned off during surgery.The issue is reported as there was a delay in treatment.(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

(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Ref- (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Ref- (b)(4).

Event Description

Ref- sw-cpl-2018-000541; tw # 173705.

Manufacturer Narrative

Getinge became aware of an incident with one of surgical lights- volista.As it was stated, the light turned off during surgery.The issue is reported as there was a delay in treatment.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.The root cause is a bad electrical connection between the spring arm and the suspension.The connector was not all the way plugged in from install.Therefore the most likely root cause is related to service.We believe the related devices are performing correctly in the market.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.

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7756497
• MDR Text Key: 116710586
• Report Number: 9710055-2018-00066
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568811950
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1