RELIANCE SYNERGY 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 2012-10-26 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.

Event Text Entries

[10485054] The steris service technician returned to the user facility to make repairs to the unit, ran a test cycle and confirmed the unit was operational. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10


[20637519] The user facility reported that water was leaking from their reliance synergy washer. No injuries or procedural delays/cancellations were reported. Some ceiling tiles on the lower level were damaged.
Patient Sequence No: 1, Text Type: D, B5


[20909807] A steris service technician inspected the unit and found a crack on the sump, just under the steam coil outlet. The technician is scheduled to make repairs to the unit.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680353-2012-00089
MDR Report Key2806716
Report Source06
Date Received2012-10-26
Date of Report2012-10-26
Date of Event2012-09-26
Date Mfgr Received2012-09-26
Date Added to Maude2013-02-05
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 NameRELIANCE SYNERGY WASHER
Generic NameWASHER
Product CodeLDS
Date Received2012-10-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2012-10-26

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