MAUDE Adverse Event Report: MAQUET SAS SPRING ARM, VERTICAL; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD567910901

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of spring arm attached to surgical light.As it was stated by customer, the dust covers were found broken, however the paint was chipping also from the covers.There was no injury reported however we decided to report the issue in abundance of caution as any paint particle falling off into sterile field or during surgery might be a source of contamination.(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.(b)(4).Exemption # e2018005.(b)(4).

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

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

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

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

The issue is 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.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

The issue is still 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 being investigated by manufacturing site.

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

Getinge became aware of an incident with one of spring arm attached to powerled surgical light.As it was stated by customer, the dust covers were found broken, and also the paint was chipping also from the covers.There was no injury reported however we decided to report the issue in abundance of caution as any paint particle falling off into sterile field or during surgery might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.There is no information provided if in the time when the event occurred the device was or was not being used for the patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand and that the reported scenario has never lead to serious injury or worse.Furthermore, it was found that the possible root causes of this event are wrong assembly of metal covers by technician (during maintenance or installation) or improper use of the device by user.Additionally, every getinge technician is informed how to properly mount the metal fitting on the spring arm.Moreover, the paint chipping could occur due to improper cleaning of the device or collision with another device.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.

Event Description

Manufacturer reference number #188366.

• Brand Name: SPRING ARM, VERTICAL
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8202860
• MDR Text Key: 131904698
• Report Number: 9710055-2018-00204
• 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,health
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD567910901
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other