TRILOGY 202 Adverse Event — Malfunction (MDR 2518422-2020-01097)
TRILOGY 202 Adverse Event — Malfunction (MDR 2518422-2020-01097) 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.
| Device | TRILOGY 202 |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | RESPIRONICS INC |
| Report number | 2518422-2020-01097 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | A 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, THE DEVICE FAILED STEPS DURING TESTING. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUES. |
| Source | openFDA MAUDE (device adverse events) |
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