MAUDE Adverse Event Report: MAQUET SAS POWERLED II 500; LAMP, SURGICAL

Model Number ARD569202913

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

E1b event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : no information about service and solution.

Event Description

On 29th february, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 500.As it was stated, paint damage occurred on the suspension arm, the problem was discovered during maintenance.It was confirmed by technician the mechanical damage occurred due to collision.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 or serious injury.

• Brand Name: POWERLED II 500
• Type of Device: LAMP, SURGICAL
• 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: 18873171
• MDR Text Key: 337301428
• Report Number: 9710055-2024-00206
• Device Sequence Number: 1
• Product Code: FTD
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569202913
• Device Catalogue Number: ARD569202913
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1