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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY RSHIELD RADIATION PROTECTION DEVICE

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STERIS CORPORATION - MONTGOMERY HARMONY RSHIELD RADIATION PROTECTION DEVICE Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and confirmed the shield had detached. The lighting system was installed in 2013 making it approximately 7 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities. The technician reattached the radiation shield, tested the lighting system, confirmed it to be operating according to specification, and returned it to service. A 3-year complaint review indicates this to be an isolated event. No additional issues have been reported.
 
Event Description
The user facility reported that as an employee attempted to move the harmony rshield radiation protection device attached to their harmony led surgical lighting system, the shield subsequently detached from the lighting system. The employee caught the shield as it detached. No report of injury.
 
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Brand NameHARMONY RSHIELD RADIATION PROTECTION DEVICE
Type of DeviceSHIELD
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 Key11079396
MDR Text Key224759516
Report Number1043572-2020-00067
Device Sequence Number1
Product Code KPY
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 12/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2020
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 Received12/02/2020
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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