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AISYS Adverse Event — Malfunction (MDR 2112667-2020-01340)

AISYS Adverse Event — Malfunction (MDR 2112667-2020-01340) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AISYS; Generic name: ANESTHESIA GAS MACHINE; Manufacturer: DATEX-OHMEDA, INC..

DeviceAISYS
Generic nameANESTHESIA GAS MACHINE
ManufacturerDATEX-OHMEDA, INC.
Report number2112667-2020-01340
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, HEALTH PROFESSIONAL, U
NarrativeA GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE FLOW SENSORS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.
SourceopenFDA MAUDE (device adverse events)

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