TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01092)
TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01092) 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..
| Device | TRILOGY 100 |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | RESPIRONICS INC. |
| Report number | 2518422-2020-01092 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT DELIVERING THE SET VOLUME. 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 WAS RECALIBRATED AND THE SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. |
| Source | openFDA MAUDE (device adverse events) |
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