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

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2014

Event Type  No Answer Provided  

Event Description

The user facility reported the hospital's maintenance department had powered off their surgical light to clean the surface.When power to the lighting system was restored, the maintenance department reported the lighting system caught on fire and began smoking.No injuries or procedural delays or cancellations were reported.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the lighting system, and identified evidence of fluid intrusion within the housing of one of the lightheads.The evidence included signs of electrical damage to the internal pc board, fluid tracks highlighted by soot, and a melted part of the lighthead due to heat from the pc board.During the cleaning, excess liquids were applied to the lighting system and entered the lighthead housing.The liquids came in contact with the internal electrical circuitry and created an electrical shortage.The technician replaced the wire harness and pc board, tested the unit, and confirmed it to be operating according to specification.The operator manual states "dampen a soft cloth with the cleaning solution and wring out the excess moisture.Thoroughly wipe the areas to be cleaned," and "wipe all surfaces with a clean dry soft cloth." the technician discussed the event and proper cleaning procedure with the or manager.

• Brand Name: HARMONY LC 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4323623
• MDR Text Key: 5130318
• Report Number: 1043572-2014-00135
• Device Sequence Number: 1
• Product Code: FTD
• 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: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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
• Date Manufacturer Received: 11/13/2014
• 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