MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-06 for BIRD 04230 manufactured by Bird Products Corp..
[239034]
Pt was receiving aggressive hemodynamic stabilization measures including central venous line, fluid resuscitation and pressors. In 2001, pt experienced cardiopulmonary failure and was started on estracorporeal membrane oxygenation cannulation. A pop-off valve was placed in the ventilating gas tubing proximal to the gas phase of the artificial lung, to prevent air embolus if occlusion of the outlet gas phase occurs. The co2 content in the pt's blood occurred before and after the oxygenation. When the pop-off valve was removed, the pco2 level on the pt and ecmo circuit decreased. The pop-off valve was measured and recorded to pop off at 30cm h20.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 359922 |
| MDR Report Key | 359922 |
| Date Received | 2001-11-06 |
| Date of Report | 2001-05-23 |
| Date of Event | 2001-02-14 |
| Report Date | 2001-05-23 |
| Date Reported to Mfgr | 2001-06-14 |
| Date Added to Maude | 2001-11-16 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIRD |
| Generic Name | VALVE, RELIEF, 30 CMH2O |
| Product Code | MNJ |
| Date Received | 2001-11-06 |
| Model Number | 04230 |
| Catalog Number | 04230 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 349105 |
| Manufacturer | BIRD PRODUCTS CORP. |
| Manufacturer Address | 1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US |
| Baseline Brand Name | BIRD |
| Baseline Generic Name | VALVE, RELIEF, 30CM H2O |
| Baseline Model No | 04230 |
| Baseline Catalog No | 04230 |
| Baseline Device Family | PT CIRCUITS AND COMPONENTS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-06 |