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U.S. Department of Health and Human Services

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

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STERIS CORPORATION - MONTGOMERY HARMONY LC SURGICAL LIGHTING SYSTEM Back to Search Results
Device Problem Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
The lighting system was manufactured in 2009 and is approximately 9 years old. It is not under a steris service agreement for maintenance activities. The user facility is responsible for all service and maintenance activities. A steris service technician arrived onsite to inspect the unit. He tested the function and articulation of the lighting system and was able to duplicate the reported event. The technician found that the root cause of the event was the on/off power button, located on the front panel of the wall control. As the on/off button was not operating properly this caused the lighting system to stop illuminating during the procedure. The technician replaced the front panel of the wall control including the on/off power button, tested the unit, confirmed it to be operating according to specification, and returned the unit to service. No additional issues have been reported.
 
Event Description
The user facility reported that during a patient procedure their harmony lc surgical lighting system stopped illuminating. No report of injury or procedure delay. The procedure was completed successfully.
 
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Brand NameHARMONY LC SURGICAL LIGHTING SYSTEM
Type of DeviceLIGHTING SYSTEM
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 Key8157733
MDR Text Key131379717
Report Number1043572-2018-00102
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
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

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