inforMED
MalfunctionFLE

ATLAS

Received Jul 23, 2024 · Event occurred Jun 19, 2024

Report 3005899764-2024-00033 · MDR key 19810636

Device

Generic name

Sterilizer

Model number

AX0660230830000013

Catalog 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.