MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED 500 SURGICAL LIGHT

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/20/2022

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure one of the harmony 500 surgical light heads went out, followed by a loud noise and smoke emitting from the wall control.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the power supply on the wall control was damaged.The loud noise and smoke reported in the event were a result of a blown fuse on the power supply.The lighting system was installed in 2010 making it approximately 12 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities.The technician made the necessary repairs, tested the unit, confirmed it was operating according to specifications, and returned it to service.No additional issues have been reported.

• Brand Name: HARMONY LED 500 SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14118046
• MDR Text Key: 289332155
• Report Number: 1043572-2022-00029
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1