MalfunctionFLF
3017 ETO STERILIZER
Received Jun 2, 2017 · Event occurred May 3, 2017
Report 3005899764-2017-00025 · MDR key 6609261
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Device Alarm System
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A PROCEDURE DELAY WAS REPORTED DUE TO THE EVENT. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THE VACUUM PUMP TRANSDUCER REQUIRED REPLACEMENT. THE VACUUM PUMP TRANSDUCER WAS NOT PROVIDING ACCURATE READINGS OF THE PRESSURE INSIDE THE CHAMBER SUBSEQUENTLY CAUSING THE "TOO LONG IN EVACUATION" ALARM. THE TECHNICIAN REPLACED THE VACUUM PUMP TRANSDUCER, TESTED THE STERILIZER AND CONFIRMED IT TO BE OPERATIONAL.
Description of Event or Problem
THE USER FACILITY REPORTED THEIR STERILIZER ALARMED FOR "TOO LONG IN EVACUATION". NO REPORT OF INJURY.