inforMED
MalfunctionFLE

AMSCO 400 STEAM STERILIZER

Received Oct 5, 2023 · Event occurred Jul 17, 2023

Report 17875611 · MDR key 17875611

Device

Generic name

Sterilizer, Steam

Manufacturer

Steris Corporation

Catalog number

SR4321224011

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ONE OF OUR THREE STERILIZERS REQUIRED MAINTENANCE AFTER THE DISPLAY BOARD ON THE UNIT STOPPED WORKING. AN ORDER WAS PLACED FOR A REPLACEMENT ON JULY 17TH, WHICH WAS FOUND TO BE ON BACKORDER WITH AN UNKNOWN SHIP DATE. THE PART WAS RECEIVED AUGUST 23RD AND INSTALLED IN THE STERILIZER, AND FURTHER TROUBLESHOOTING FOUND ANOTHER COMPONENT WAS REQUIRED, A POWER SUPPLY. THAT PART WAS ORDERED ON THE SAME DAY, AUGUST 23RD, AND WAS AGAIN FOUND TO BE ON BACK ORDER WITH AN UNKNOWN SHIP DATE. IT WAS DELIVERED ON SEPTEMBER 20TH. THIS RESULTED IN THE UNIT BEING DOWN FOR JUST OVER 2 MONTHS AND REDUCING WORKFLOW IN THE DEPARTMENT BY A THIRD. WHEN WE INQUIRED ABOUT THE DELAYS LATER, WE FOUND OUT STERIS HAD RECENTLY MOVED ITS WAREHOUSE AND WAS EXPERIENCING DELAYS IN SHIPPING BECAUSE OF THAT. MANUFACTURER RESPONSE FOR STERILIZER, STEAM, AMSCO (PER SITE REPORTER). THEY WERE SORRY FOR THE DELAY BUT WERE NOT ABLE TO ASSIST IN COMMUNICATION OR THE EXPEDITION OF THE ORDERED EQUIPMENT.