MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-03-25 for CO2 TANK manufactured by .
[20322663]
Post op patient connected to portable medical gas tank for transport. Oxygen saturation dropped. Patient cardiac arrested. Found that patient 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 adapters indicate oxygen. What was the original intended procedure? Delivery of oxygen.
Patient Sequence No: 1, Text Type: D, B5
[20500869]
Initial reporter (b)(6) was contacted and she stated "i am unable to determine the mfr of the tank. There were words and numbers stamped into the metal of the tank. They were very difficult to read. We were able to make out the word ohio, but that was about it. That does not necessarily mean the tank was made by your company. I am not sure how the medwatch folks linked the tank to your company. It could be an error. " ohio medical does not mfr or distribute co2 tanks.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419185-2014-00002 |
| MDR Report Key | 4172019 |
| Report Source | 99 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-25 |
| Date of Event | 2014-01-22 |
| Date Added to Maude | 2014-10-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO2 TANK |
| Generic Name | CYLINDER, COMPRESSED GAS AND VALVE |
| Product Code | ECX |
| Date Received | 2014-03-25 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-25 |