AMSCO 600 SG+ STERILIZER
Received Jun 21, 2024 · Event occurred May 24, 2024
Report 3005899764-2024-00028 · MDR key 19579946
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Smoking
- Smoking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN DETERMINED THAT DURING THE INSTALLATION OF THE STERILIZER THE CONTROL BOX WAS MISWIRED, SUBSEQUENTLY CAUSING THE UNIT TO SHORT CIRCUIT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE CONTROL BOX AND WIRE HARNESS. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED TO SERVICE. THE INSTALLATION TECHNICIAN WAS RETRAINED ON THE PROPER INSTALLATION OF THE AMSCO 600 STERILIZER. THIS IS CONSIDERED AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM TWO OF THEIR AMSCO 600 STERILIZERS DURING THE INSTALLATION OF THE STERILIZERS. NO REPORT OF INJURY.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.