MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-11-06 for * manufactured by Bird Products Corp..
[237177]
Pt was placed on extracorporeal membrane oxygen cannulation. To prevent over-pressurization to the pt, a pop-off was used to fit in the oxygenator gas line. The co2 in the pt's blood elevated, before and after oxygenation. When the pop off valves were from all circuits, the pco2 level on the pt and the ecmo circuit decreased. The pop-off valves were measured and recorded to pop off at 30cmh2o.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2001-00146 |
| MDR Report Key | 359920 |
| Report Source | 06 |
| Date Received | 2001-11-06 |
| Date of Event | 2001-02-07 |
| Date Mfgr Received | 2001-06-06 |
| Date Added to Maude | 2001-11-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TOMORRA RIES |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal | 92262 |
| Manufacturer Phone | 7607787615 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | MNJ |
| Date Received | 2001-11-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 349103 |
| Manufacturer | BIRD PRODUCTS CORP. |
| Manufacturer Address | 1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-11-06 |