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

Model Number ARD568370931

Device Problems Detachment of Device or Device Component (2907); Installation-Related Problem (2965)

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

Event Date 05/26/2023

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 26th may 2023 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.As it was stated, upon the preventive maintenance activities being performed on the device, loose connection of the anchorage to the ceiling was identified and confirmed by the photographic evidence.According to the getinge service technician, only three threaded rods were supporting the configuration whereas normally the device should be secured by six rods.There was no injury reported, however, we decided to report the issue in abundance of caution as loose connection of the device to the ceiling may lead to the detachment of whole configuration and serious injury.

• 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
• 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: 17065999
• MDR Text Key: 316611621
• Report Number: 9710055-2023-00423
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ARD568370931
• Device Catalogue Number: ARD568370931
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1