MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED 585 SURGICAL LIGHTING SYSTEM

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found that the wiring harness of the power supply was damaged.The technician replaced the wall control, tested the lighting system, confirmed it to be operating according to specification, and returned it to service.The wall control subject of the event will be returned to steris for evaluation; a follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that smoke was emitting from the wall control of their harmony led 585 surgical lighting system at the end of a procedure when the patient was being transferred to an or bed.The power to the lighting system was turn off and the smoking stopped.No report of injury.

Manufacturer Narrative

The wall control subject of the event was returned to steris for evaluation and it was determined that the root cause of the reported event was an electrical short.The cause of the short could not be determined due to the damage to the wiring.No additional issues have been reported.

• Brand Name: HARMONY LED 585 SURGICAL LIGHTING SYSTEM
• Type of Device: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• MDR Report Key: 10428216
• MDR Text Key: 204078153
• Report Number: 1043572-2020-00036
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1