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

Device Problem Decoupling (1145)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 28th may, 2019 maquet (b)(4) became aware of an issue with one of surgical lights- powerled.As it was stated, one for the six screws has the head cut.There was no injury reported however we decided to report the issue in abundance of caution as any defect of the screws involved in this complaint may lead to the detachment of the whole configuration.

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

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 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

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 became aware of an issue with one of surgical lights- powerled.As it was stated, one for the six screws has the head cut.There was no injury reported however we decided to report the issue in abundance of caution as any defect of the screws involved in this complaint may lead to the detachment of the whole configuration.It was established that when the event occurred, the surgical light did not meet its specification.There is no information if at the time when the event occurred the device was being used for the patient treatment.Mechanical fatigue may have different origins, including but not limited to a screwing torque non-compliant with specifications applied during installation or periodic maintenance, a misuse or unexpected handling of the device or a screw design not adapted to the intended use.The investigations performed until today could not confirm or remove any of these options except the design of the device.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

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: 8653420
• MDR Text Key: 146477974
• Report Number: 9710055-2019-00185
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1