CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for CAVIWAVE PRO ULTRASONIC CLEANING SYSTEM manufactured by Steris Corporation - Distribution Center.

Event Text Entries

[89936294] The user facility initially reported that a burning smell and small fire were emitting from the caviwave cleaner. No instruments were present during the time of the reported event. A steris service technician arrived onsite to inspect the unit. Contrary to the reported event, the technician found no evidence of fire damage inside the unit. The technician inspected the unit's electrical components and wiring and found no evidence of smoke or fire. The technician further inspected the unit's generator and found no blown fuses. Prior to the steris service technician's arrival, the user facility's biomedical technician inspected the unit and found that one of the contactors required replacement. The steris technician was able to inspect the contactor and observed a brown discoloration. The cause of the discoloration is attributed to an electrical short condition due to loose wiring at a contactor terminal. The steris service technician replaced the contactor, ran a test cycle and returned the unit to service. No additional issues have been reported. The caviwave ultrasonic cleaner was installed in 2013 and is serviced and maintained by the user facility's 3rd party maintenance provider. The cause of the loose wiring is attributed to lack of preventive maintenance. The steris service technician found five contactor terminal screws required a half turn before they were found to be tight. The preventive maintenance guide states (2x/year), "verify all wire terminal ends at all terminals, terminal strips, relays, contactors, plc and connections are correctly installed, secure, and properly torqued. Ensure no wires show any signs of overheating or discoloration. " a steris district service manager (dsm) stated the user facility's 3rd party maintenance provider has purchased the maintenance manuals and have conducted their own biomedical training on the caviwave cleaners.
Patient Sequence No: 1, Text Type: N, H10


[89936295] The user facility reported that a burning smell was emitting from their caviwave ultrasonic cleaner. No report of injury, procedure delay or cancellation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003950207-2017-00007
MDR Report Key6918432
Date Received2017-10-05
Date of Report2017-10-05
Date of Event2017-09-07
Date Mfgr Received2017-09-07
Date Added to Maude2017-10-05
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 FDA3
Event Location3
Manufacturer ContactMR. DANIEL DAVY
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927453
Manufacturer G1STERIS CORPORATION - DISTRIBUTION CENTER
Manufacturer Street6100 HEISLEY RD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal Code44060
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAVIWAVE PRO ULTRASONIC CLEANING SYSTEM
Generic NameCLEANING SYSTEM
Product CodeFLG
Date Received2017-10-05
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION - DISTRIBUTION CENTER
Manufacturer Address6100 HEISLEY RD MENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-05

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