HARMONY RSHIELD RADIATION PROTECTION DEVICE
Received Dec 28, 2020 · Event occurred Dec 2, 2020
Report 1043572-2020-00067 · MDR key 11079396
Device
Generic name
Shield
Manufacturer
Steris Corporation - MontgomeryProduct problems
- Detachment of Device or Device Component
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional 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.
Description of Event or Problem
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.