MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-22 for CO2 TANK * manufactured by Ohio Medical.
[19919541]
Post-op patient connected to portable medical gas tank for transport. Oxygen saturation dropped. Patient cardiac arrested. Found that pt was connected to a co2 tank. Patient was successfully resuscitated. The co2 tank had a green plastic adapter (cone shaped adapter) on the regulator nozzle. Green adaptors indicate oxygen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3624023 |
| MDR Report Key | 3624023 |
| Date Received | 2014-01-22 |
| Date of Report | 2014-01-22 |
| Date of Event | 2014-01-22 |
| Report Date | 2014-01-22 |
| Date Reported to FDA | 2014-01-22 |
| Date Reported to Mfgr | 2014-02-12 |
| Date Added to Maude | 2014-02-12 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO2 TANK |
| Generic Name | CYLINDER, COMPRESSED GAS, AND VALVE |
| Product Code | ECX |
| Date Received | 2014-01-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031409 US 60031 4099 |
| Brand Name | GREEN REGULATOR |
| Generic Name | REGULATOR, PRESSURE, GAS CYLINDER |
| Product Code | CAN |
| Date Received | 2014-01-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | WESTERN MEDICAL |
| Manufacturer Address | 1001 N. TUSTIN AVE, SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-22 |