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

Model Number ARD568350905

Device Problems Peeled/Delaminated (1454); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

The initial reporter: electromedicine service.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 20th december, 2023 getinge became aware of an issue with one of surgical lights - hled.As it was stated, the brakes cannot be removed because the arm axis is a little fallen.The designated complaint unit employee found on photographic evidence the paint chipping occurred on the suspension arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

Manufacturer Narrative

The correction of b5 describe event and problem and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 20th december, 2023 getinge became aware of an issue with one of surgical lights - hled.As it was stated, the brakes cannot be removed because the arm axis is a little fallen.The designated complaint unit employee found on photographic evidence the paint chipping occurred on the suspension arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.Corrected b5 describe event and problem: on 20th december, 2023 getinge became aware of an issue with one of surgical lights - hled.The received customer allegation regarded a non-reportable issue.The designated complaint unit employee found on photographic evidence the paint chipping occurred on the suspension arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.Further information provided by getinge employee indicated that there was no chipping paint from the suspension arm and the device is only dirty.It was stated the device was cleaned.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of paint chipping, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: material integrity problem|degraded|peeled/delaminated|1454.Corrected h6 medical device ¿ problem code: contamination /decontamination problem|device reprocessing problem|failure to clean adequately|4048.Previous h6 medical device ¿ component codes: mechanical|coating material||4768.Corrected h6 medical device ¿ component codes: none.Previous h6 investigation findings: results pending completion of investigation 3233.Corrected h6 investigation findings: none.Previous b11 investigation conclusions : conclusion not yet available 11.Corrected b11 investigation conclusions : cause traced to user 19.Initially provided information was pointing to paint peeling from the suspension arm.The issue is considered as safety related as any particles falling off into sterile field or during procedure may cause contamination.According to additional clarification provided by the getinge technician, the initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as there was no indication of missing particles.The investigation was performed.The investigated scenarios did not cause risk to human life.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

Event Description

On 20th december, 2023 getinge became aware of an issue with one of surgical lights - hled.The received customer allegation regarded a non-reportable issue.The designated complaint unit employee found on photographic evidence the paint chipping occurred on the suspension arm.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.Further information provided by getinge employee indicated that there was no chipping paint from the suspension arm and the device is only dirty.It was stated the device was cleaned.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of paint chipping, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• 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
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 18382475
• MDR Text Key: 331248954
• Report Number: 9710055-2023-00980
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: ARD568350905
• Device Catalogue Number: ARD568350905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1