FDA Adverse Event Malfunction Summary report: N

SYSTEM 1E PROCESSOR

MDR report key: 7290601 · Received February 22, 2018

Report

Report Number: 9680353-2018-00016
Event Type: Malfunction
Date Received: February 22, 2018
Date of Event: January 23, 2018
Report Date: February 22, 2018
Manufacturer: STERIS CANADA CORPORATION
Product Code: NZA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO REPORT OF PROCEDURE DELAY OR CANCELLATION. FOLLOWING THE REPORTED EVENT, A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT. THE TECHNICIAN FOUND THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATION; NO REPAIRS WERE REQUIRED. WHILE ON-SITE, THE TECHNICIAN IDENTIFIED THAT THE USER FACILITY'S WORK ROOM WHERE THE SYSTEM 1E PROCESSOR IS LOCATED HAS INADEQUATE AIR CIRCULATION. A STERIS ACCOUNT MANGER SPOKE TO THE FACILITY'S PERSONNEL REGARDING VENTILATION OPTIONS TO THE WORK ROOM WHERE THE SYSTEM 1E IS LOCATED. THE USER FACILITY WILL WORK TOWARDS ADDING VENTILATION TO THE WORK ROOM. SECTION 3-3 OF THE SYSTEM 1E OPERATOR MANUAL STATE "THE STERILANT CONCENTRATE SHOULD BE USED IN A WELL VENTILATED ROOM. CONFORMANCE TO AAMI ST58 IS RECOMMENDED". THE SYSTEM 1E OPERATOR MANUAL (2-2) STATES, "WARNING: TO AVOID ACCUMULATED CONCENTRATION OF PERACETIC ACID VAPOR, USE S40 STERILANT CONCENTRATE IN A WELL VENTILATED ROOM OR AREA." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT THEIR SYSTEM 1E PROCESSOR WAS EMITTING AN ODOR. AN EMPLOYEE EXPERIENCED A MILD HEADACHE AS A RESULT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE CONTINUED WORKING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
131538	SYSTEM 1E PROCESSOR	PROCESSOR	NZA	STERIS CANADA CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1