MalfunctionFLE

STERIS CORPORATION PREVAC STEAM STERILIZER

Received Jun 6, 2024

Report MW5155877 · MDR key 19484010

Device

Generic name

Sterilizer, Steam

Manufacturer

Steris Mexico, S. De R.l. De C.v.

Model number

AMSCO 600

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

PMS OF 3 STERILIZERS WERE CLOSED OUT SIDE THE MONTH +/- 10 DAY WINDOW FOR COMPLETING SCHEDULED PLANNED MAINTENANCE. THIS WAS DUE TO THE CONTRACTED OEMS INABILITY TO PRODUCE THE PM KITS NEEDED FOR THE EQUIPMENT DUE FOR PM. S/NS (B)(6). REF REPORTS: MW5155875, MW5155876.