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TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01094)

TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01094) 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 number2518422-2020-01094
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, HEALTH PROFESSIONAL
NarrativeTHE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, PHYSICAL DAMAGE WAS OBSERVED TO
SourceopenFDA MAUDE (device adverse events)

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