MAUDE Adverse Event Report: MAQUET SAS POWERLED 500; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568350933

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled 500.As it was stated, the headlight handle fell off due to defective thread and ring of the handle holder.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

• Brand Name: POWERLED 500
• 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: 19057852
• MDR Text Key: 339557232
• Report Number: 9710055-2024-00252
• 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
• Report Date: 04/08/2024

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 Operator: Health Professional
• Device Model Number: ARD568350933
• Device Catalogue Number: ARD568350933
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1