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TRILOGY 202 Adverse Event — Malfunction (MDR 2518422-2020-01096)

TRILOGY 202 Adverse Event — Malfunction (MDR 2518422-2020-01096) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TRILOGY 202; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: RESPIRONICS INC.

DeviceTRILOGY 202
Generic nameVENTILATOR, CONTINUOUS, FACILITY USE
ManufacturerRESPIRONICS INC
Report number2518422-2020-01096
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE
NarrativeA VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.
SourceopenFDA MAUDE (device adverse events)

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