TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01065)
TRILOGY 100 Adverse Event — Malfunction (MDR 2518422-2020-01065) 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 | 2518422-2020-01065 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, USER FACILITY |
| Narrative | THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR "SERVICE REQUIRED" ALARM CONDITION RELATED TO LOW INSPIRATORY PRESSURE OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND OVERHEAD BLOWER FILTER WERE REPLACED TO ADDRESS THE ISSUE. |
| Source | openFDA MAUDE (device adverse events) |
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