MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-30 for TRILOGY O2 1040004 manufactured by Respironics Inc..
[185543091]
A ventilator was returned to the manufacturer for service. 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 oxygen blending module board was replaced to address the issue. During the evaluation of the device at the manufacturer's service center, the device failed a step during testing. The device's active exhalation control module was replaced to address the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2020-00812 |
| MDR Report Key | 9897961 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2014-12-02 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON, PA |
| Manufacturer Country | US |
| Manufacturer G1 | RESPIRONICS INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRILOGY O2 |
| Generic Name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Product Code | CBK |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 1040004 |
| Catalog Number | 1040004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |