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

Model Number ARD568531710C

Device Problem Electrical /Electronic Property Problem (1198)

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 30th december, 2020 getinge became aware of an issue with one of surgical lights - hled.As it was stated, customer requested service in order to organize the surgical light cables which were located below the ceiling line.The getinge service technician who arrived at site confirmed the surgical light¿s cables hanging without any protection.There was no information if the device was used in the condition shown on the pictures, however we decided to report this case in abundance of caution as it could have led to particles, such as dust or similar falling from the not closed ceiling area into the sterile field and consequently, created a contamination risk.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hled.As it was stated, customer requested service in order to organize the surgical light cables, which were located below the ceiling line.The getinge service technician who arrived at site confirmed the surgical light¿s cables hanging without any protection.There was no information if the device was used in the condition shown on the pictures, however we decided to report this case in abundance of caution as it could have led to particles, such as dust or similar falling from the not closed ceiling area into the sterile field and consequently, could create a contamination risk.It was established that when the event occurred, the surgical light met its specification as the issue was facility related, however it contributed to the event.We have not received information whether the device was being used for patient treatment at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Manufacturing site has investigated the issue.According to the subject matter expert, the air supply ceiling was unfinished.The panels of the laminar flow are missing and they were not maquet sas product.Maquet configuration was conform.Therefore, we assume that the issue is user and installation related.

Event Description

Manufacturer reference number (b)(4).

• 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: 11214884
• MDR Text Key: 239492606
• Report Number: 9710055-2021-00020
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2021

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?: No
• Device Operator: No Information
• Device Model Number: ARD568531710C
• Device Catalogue Number: ARD568531710C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 02/26/2021; 06/01/2021
• Supplement Dates FDA Received: 03/23/2021; 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1