MAUDE Adverse Event Report: MAQUET SAS POWERLED 300; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568331999G

Device Problems Naturally Worn (2988); No Apparent Adverse Event (3189)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 6th december, 2023 getinge became aware of an issue with one of surgical lights - power led 300.It was stated the safety segment was already worn out.There was no injury reported, however, we decided to report the issue in abundance of caution as defective safety segment could result in a detachment of fork and dome and as a result of that, could lead to serious injury.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled 300.It was stated the safety segment was already worn out.There was no injury reported, however, we decided to report the issue in abundance of caution as defective safety segment could result in a detachment of fork and dome and as a result of that, could lead to serious injury.Further information provided by manufacturer and getinge technician indicated that affected part was replaced not because of deficiency, but as a preventive action during curative maintenance for other parts.Based on additional input it was possible to determine that the issue investigated herein is not safety and risk related, as malfunction was detected, and the part was replaced in scope of preventive maintenance.Therefore, the scenario described in the record is considered as non-reportable.

Manufacturer Narrative

The initial reporter was hospital's technical director.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 (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled 300.It was stated the safety segment was already worn out.There was no injury reported, however, we decided to report the issue in abundance of caution as defective safety segment could result in a detachment of fork and dome and as a result of that, could lead to serious injury.Corrected b5 describe event and problem: on (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled 300.It was stated the safety segment was already worn out.There was no injury reported, however, we decided to report the issue in abundance of caution as defective safety segment could result in a detachment of fork and dome and as a result of that, could lead to serious injury.Further information provided by manufacturer and getinge technician indicated that affected part was replaced not because of deficiency, but as a preventive action during curative maintenance for other parts.Based on additional input it was possible to determine that the issue investigated herein is not safety and risk related, as malfunction was detected, and the part was replaced in scope of preventive maintenance.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907 corrected h6 medical device ¿ problem code: no apparent adverse event|||3189 initially provided information was pointing to potential detachment of fork and dome.The issue is considered as safety related as defective safety segment could result in a detachment of fork and dome and as a result of that, could lead to serious injury.According to additional clarification provided by the manufacturer and getinge technician, the initial information wasn't clear.It was determined that the issue investigated herein is not safety and risk related as the affected part was replaced not because of deficiency, but as a preventive action during curative maintenance for other parts.Therefore, the scenario described in the record is considered as non-reportable.It was established that when the event occurred, the device was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• Brand Name: POWERLED 300
• 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: 18318710
• MDR Text Key: 330385000
• Report Number: 9710055-2023-00956
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/13/2023

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 Model Number: ARD568331999G
• Device Catalogue Number: ARD568331999G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1