AMSCO 1215 CART & UTENSIL WASHER/DISINFECTOR
Received May 9, 2024 · Event occurred Apr 9, 2024
Report 9680353-2024-00015 · MDR key 19280299
Device
Generic name
Washer/disinfector
Manufacturer
Steris Canada UlcProduct problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Bruise/Contusion
- Bruise/Contusion
Narrative
Additional Manufacturer Narrative
DURING THE STERIS SERVICE TECHNICIAN'S FOLLOW UP WITH USER FACILITY PERSONNEL, IT WAS STATED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT HAD PLACED A CONTAINER LID ON TOP OF THE UNIVERSAL RACK. THE CONTAINER LID WAS POINTING OUTWARD AND HIT THE TOP PANEL WHEN THE EMPLOYEE PUSHED THE RACK INTO THE AMSCO 1215 CART & UTENSIL WASHER/DISINFECTOR SUBSEQUENTLY CAUSING THE REPORTED EVENT TO OCCUR. USER FACILITY PERSONNEL STATED TO THE STERIS SERVICE TECHNICIAN THAT THE TOP PANEL HAD NOT BEEN SECURED WITH MOUNTING SCREWS AT THE TIME OF THE REPORTED EVENT. THE STERIS SERVICE TECHNICIAN'S INSPECTION OF THE AMSCO 1215 CART & UTENSIL WASHER/DISINFECTOR CONFIRMED THAT THE MOUNTING SCREWS WERE PRESENT HOWEVER, THE SCREWS MAY HAVE BEEN LOOSE AT THE TIME OF THE EVENT SUBSEQUENTLY CAUSING THE PANEL TO LIFT AND FALL WHEN THE CONTAINER LID STRUCK THE PANEL FROM THE BOTTOM WHEN THE EMPLOYEE WAS LOADING THE RACK INTO THE UNIT. THE STERIS SERVICE TECHNICIAN REINSTALLED THE PANEL, CONFIRMED THE MOUNTING SCREWS WERE PROPERLY TIGHTENED, TESTED THE UNIT, AND RETURNED THE AMSCO 1215 CART & UTENSIL WASHER/DISINFECTOR TO SERVICE. THE STERIS SERVICE TECHNICIAN COUNSELED USER FACILITY PERSONNEL OF THE PROPER LOADING TECHNIQUES AND ENSURING NO ITEMS ARE STICKING OUT OF THE RACK. THE OPERATOR MANUAL STATES (SECTION 4.5), "WHEN LOADING UNIVERSAL RACK, ENSURE NO ITEMS STICK OUT OF RACK." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS LOADING THEIR AMSCO 1215 CART & UTENSIL WASHER/DISINFECTOR, THE TOP PANEL FELL OFF AND HIT THE EMPLOYEE IN THE FOREHEAD. THE EMPLOYEE SOUGHT AND RECEIVED MEDICAL TREATMENT AND RETURNED TO WORK.