MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-31 for TRILOGY 100 1054260 manufactured by Respironics, Inc.
[185710828]
A ventilator was returned to a third party service center for evaluation. The device was not in patient use. During the evaluation of the ventilator at the third party service center, a failure of the device to power on was observed. The device's system board was replaced to address the issue. The device's active exhalation control module was found to be physically damaged and was replaced to address the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2020-00800 |
| MDR Report Key | 9902726 |
| Report Source | OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-02-19 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM PRICE |
| Manufacturer Street | 312 ALVIN DR. |
| Manufacturer City | NEW KENSINGTON, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 3349303 |
| Manufacturer G1 | RESPIRONICS, INC |
| Manufacturer Street | 1001 MURRY RIDGE RD |
| Manufacturer City | MURRYSVILLE, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRILOGY 100 |
| Generic Name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Product Code | CBK |
| Date Received | 2020-03-31 |
| Model Number | 1054260 |
| Catalog Number | 1054260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC |
| Manufacturer Address | 1001 MURRY RIDGE RD MURRYSVILLE, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |