ATLAS
Received Jul 23, 2024 · Event occurred Jun 19, 2024
Report 3005899764-2024-00033 · MDR key 19810636
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Model number
AX0660230830000013Catalog number
AX0660230830000013
Product problems
- Failure to Align
- Failure to Align
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE LOADING CARRIAGE WAS NOT ALIGNED TO THE RAIL INSIDE THE STERILIZER. THE TECHNICIAN NOTED THAT THE LOADING CARRIAGE WAS MISALIGNED DUE TO THE WEAR ON THE FRONT WHEELS OF THE LOADING CARRIAGE. THE UNIT IS NOT UNDER STERIS CONTRACT FOR MAINTENANCE SERVICES. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE WHEELS AND ADJUSTED THE RAIL AND CARRIAGE HEIGHT INSIDE THE STERILIZER. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE INJURED THEIR SHOULDER WHILE OPERATING AN ATLAS TRANSFER CARRIAGE. MEDICAL TREATMENT WAS SOUGHT AND ADMINISTERED. IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.