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

Model Number ARD568370953

Device Problem Particulates (1451)

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

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6), 2019 getinge became aware of an issue with one of surgical lights- hled.As it was stated, grease has fallen from the metal plate between suspension arm and spring arm.There was no injury reported however we decided to report the issue in abundance of caution, as any foreign objects falling off into sterile field or during procedure might be a source of contamination.

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's reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights- hled.As it was stated initially, we received the indication that grease had fallen from the metal plate between suspension arm and spring arm.There was no injury reported however we decided to report the issue in abundance of caution, as any foreign objects falling off into sterile field or during procedure 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 the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that there is no apparent trend in the complaints.Per investigation by subject matter experts at the manufacturing site, the issue was not actually grease dripping, rather the witnessed phenomenon most likely appeared after an exposure to humidity when air conditioning is turned off.The dripping observed is actually a mix of water and oil.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 ot246158.

• Brand Name: HLED
• 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: 9005826
• MDR Text Key: 175198117
• Report Number: 9710055-2019-00269
• 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: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568370953
• Device Catalogue Number: ARD568370953
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 09/06/2019; 09/06/2019; 11/07/2019; 02/05/2020
• Supplement Dates FDA Received: 10/08/2019; 10/31/2019; 11/27/2019; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1