AMSCO CENTURY STERILIZER V116

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for AMSCO CENTURY STERILIZER V116 manufactured by Steris Corporation.

Event Text Entries

[177188658] Flash autoclave malfunctioned because it did not reach the proper temperature.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9652551
MDR Report Key9652551
Date Received2020-01-31
Date of Report2020-01-29
Date of Event2020-01-28
Report Date2020-01-29
Date Reported to FDA2020-01-29
Date Reported to Mfgr2020-01-31
Date Added to Maude2020-01-31
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMSCO CENTURY STERILIZER V116
Generic NameSTERILIZER, STEAM
Product CodeFLE
Date Received2020-01-31
Model NumberV116
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION
Manufacturer Address5960 HEISLEY RD MENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-31

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