1227 CART WASHER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-08 for 1227 CART WASHER manufactured by Steris Canada Corporation.

Event Text Entries

[4787618] The user facility reported that a cycle aborted with a message of "alarm #44-unload door open during cycle". The employee opened the unload door and vapor released subsequently setting off the sprinkler system. No fire alarms were triggered and the fire department was not dispatched. No evacuations were reported. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5


[12398156] A steris service technician arrived onsite and found the unload door to be open and the cart washer to be turned off via the emergency stop switch on the unload side of the washer. The technician ran several cycles and could not duplicate the reported event. The technician replaced the unload door switch, ran test cycles and confirmed the washer to be operational. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680353-2014-00083
MDR Report Key4152736
Report Source06
Date Received2014-10-08
Date of Report2014-10-08
Date of Event2014-09-09
Date Mfgr Received2014-09-09
Date Added to Maude2014-10-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS KATHRYN CADORETTE
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927231
Manufacturer G1STERIS CANADA CORPORATION
Manufacturer Street490, ARMAND-PARIS
Manufacturer CityQUEBEC, QUEBEC GIC8A3
Manufacturer CountryCA
Manufacturer Postal CodeGIC 8A3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1227 CART WASHER
Generic NameWASHER
Product CodeFLH
Date Received2014-10-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CANADA CORPORATION
Manufacturer Address490 ARMAND-PARIS QUEBEC, QUEBEC GIC8A3 CA GIC 8A3


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-08

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