MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for VENTILATOR, NON-CONTINUOUS (RESPIRATOR) manufactured by Respironics, Inc..
[185223569]
Staff called to patient's room for act. Patient in respiratory distress, gasping, increased o2 consumption from 3 to 9 liters per minute. Attempted to place on niv, however was unable to remove clear vented elbow to replace the blue unvented elbow causing approximately a ten minute delay in placement of patient on niv. Patient improved after approximately ten minutes on niv rr 23 unlabored, on niv, alert -- responding to name.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888534 |
| MDR Report Key | 9888534 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-08-08 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-03-27 |
| Lot Number | 190212 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |