inforMED
MalfunctionFLE

AMSCO

Received Oct 8, 2024 · Event occurred Sep 7, 2024

Report 3005899764-2024-00054 · MDR key 20402503

Device

Generic name

Amsco 400 Steam Sterilizer

Catalog number

SR2321213011

Product problems

  • Device Fell
  • Device Fell

Patient

NA · Unknown

  • Pain
  • Pain

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE SUFFERED AN INJURY AFTER A DOOR PANEL FELL ON THEIR FEET WHILE OPERATING A MEDIUM AMSCO 400 STERILIZER. THE EMPLOYEE RECEIVED MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN WHAT TYPE OF TREATMENT WAS ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE DOOR WAS OPENING PAST THE APPROPRIATE LIMIT, SUBSEQUENTLY CAUSING THE SIDE PANEL, DOOR SHELL, HINGES AND CONNECTING BRACKET TO BEND. WHILE BENDING, THE CONNECTING BRACKET PUSHED THE LOWER DOOR PANEL DOWNWARD, CAUSING THE PANEL TO RELEASE AND FALL ONTO THE AFFECTED EMPLOYEE'S FEET. TO RESOLVE THE ISSUE, THE TECHNICIAN ADJUSTED THE DOOR STOP TO PREVENT THE DOOR FROM OPENING BEYOND THE APPROPRIATE LIMIT AND REPAIRED THE PANELS AND BRACKETS. THE UNIT WAS CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.