MAUDE Adverse Event Report: MAQUET SAS POWERLED 700; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568370931

Device Problem Break (1069)

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

Event Date 02/01/2024

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 (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the dome stops were broken.Due that fact the stop function is no longer present, which is related to an unusual abrasion of the head screws, and therefore, can generate metal fillings.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: POWERLED 700
• 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: 18720671
• MDR Text Key: 336638839
• Report Number: 9710055-2024-00160
• 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: 02/16/2024

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: ARD568370931
• Device Catalogue Number: ARD568370931
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1