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TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01091)

TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01091) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TRILOGY 100; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: RESPIRONICS INC..

DeviceTRILOGY 100
Generic nameVENTILATOR, CONTINUOUS, FACILITY USE
ManufacturerRESPIRONICS INC.
Report number2518422-2020-01091
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, HEALTH PROFESSIONAL
NarrativeA VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE . THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S SENSOR BOARD NEEDS REPLACED TO ADDRESS THE ISSUE.
SourceopenFDA MAUDE (device adverse events)

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