MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-27 for CIRCULATOR, BREATHING-CIRCUIT manufactured by Unknown.
[48225580]
Patient Sequence No: 1, Text Type: N, H10
[48225581]
At 0750 the rt notified staff that a red fluid was in the tubing coming from the cpap ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5750581 |
| MDR Report Key | 5750581 |
| Date Received | 2016-06-27 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-06-04 |
| Report Date | 2016-06-15 |
| Date Reported to FDA | 2016-06-15 |
| Date Reported to Mfgr | 2016-06-15 |
| Date Added to Maude | 2016-06-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | CIRCULATOR, BREATHING-CIRCUIT |
| Product Code | CAG |
| Date Received | 2016-06-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-27 |