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

Model Number ARD568370938

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical light powerled.As it was stated, the water was dripping from surgical light.Taking under consideration collected up to date information we decided to report this case based on potential as any drop of water could fall into sterile field and might cause contamination.

Manufacturer Narrative

Issue is still being investigated by the manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical light powerled.As it was stated, the water was dripping from surgical light.Taking under consideration collected up to date information we decided to report this case based on potential as any drop of water could fall into sterile field and might cause contamination.It was established that when the event occurred, the light head met its specification and it contributed to the event.At the time when the event occurred the device was not being used for the patient treatment.The manufacturer subject matter experts have investigated the issue and unfortunately, the specific root cause wasn¿t established as pictures weren¿t provided.The assumption is that water leaked from the roof of the building.Particular attention should be taken of this configuration over time as there is a risk of rust appearance in the suspension and spring arm, risk of seizure and corrosion caused by moisture, destruction of the metal and damage of the electronic components.Therefore, we conclude that the issue is related to user error.Given the circumstances and the fact that it is single and isolated event 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; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9985437
• MDR Text Key: 189918954
• Report Number: 9710055-2020-00092
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2020

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: Health Professional
• Device Model Number: ARD568370938
• Device Catalogue Number: ARD568370938
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 06/09/2020; 08/21/2020
• Supplement Dates FDA Received: 07/03/2020; 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1