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

Model Number ARD568521010A

Device Problem Overheating of Device (1437)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1 event site name and address: (b)(6).H3 other text : device not returned to the manufacturer.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of surgical lights ¿ hled 500/700.According to the customer allegation, the temperature of the lights was high during normal use.There was no injury reported, however, we decided to report the issue in abundance of caution as excessive heat produced by the lights may cause serious injury in case of event reoccurrence.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

It appeared that the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00496) is a duplicate of the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00495).Therefore, the issue is evaluated under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00495).The correction of d4 catalog # and serial # deems required.This is based on the internal evaluation.Previous catalog #: ard568521010a.Corrected catalog #:ard568370957.Previous serial #: (b)(6).Corrected serial #: (b)(6).

• Brand Name: HLED
• 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: 17277082
• MDR Text Key: 318568828
• Report Number: 9710055-2023-00496
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568521010A
• Device Catalogue Number: ARD568521010A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1