120 RELIANCE 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 2012-12-14 for 120 RELIANCE CART WASHER manufactured by Steris Canada Corporation.

Event Text Entries

[3180079] The user facility reported that their 120l cart washer was leaking steam. The steam activated the user facility's sprinkler system and water was released. The fire department was dispatched but the user facility was not evacuated as the event occurred overnight. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5


[10485890] A steris service technician inspected the washer and found that the water booster tank had overheated. This was due to the steam valve having a small cut in the seat. This allowed steam to leak through subsequently setting off the sprinkler system. The technician stated that the unit was left on in an idle state overnight and that the water booster tank is connected to the user facility's steam supply line. The technician repaired the unit, ran a test cycle and confirmed it to be operational.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680353-2012-00122
MDR Report Key2873932
Report Source06
Date Received2012-12-14
Date of Report2012-12-14
Date of Event2012-11-17
Date Mfgr Received2012-11-17
Date Added to Maude2013-03-20
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 LINDSEY MCGOWAN
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927519
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 Name120 RELIANCE CART WASHER
Generic NameWASHER
Product CodeLDS
Date Received2012-12-14
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 2012-12-14

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