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

Model Number ARD568370938/ARD568350938

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 05/13/2023

Event Type  Injury  

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) 2023 getinge became aware of an event with one of surgical lights power led.As it was stated, burns occurred around the neck of the nurse who used powerled installed at the hospital.The customer alleged that is was related to the usage of getinge device.The person involved was diagnosed with second degree burns,  was prescribed medicine and received skin burn treatment at the dermatologist.The outcome as described is consider to meet the definition of a 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: 16961095
• MDR Text Key: 315546005
• Report Number: 9710055-2023-00382
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARD568370938/ARD568350938
• Device Catalogue Number: ARD568370938/ARD568350938
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female