MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-05 for OXYGEN * manufactured by Not Given.
[376225]
Rptr would like to alert physicians and, more importantly, hospitals to a lethal situation which can be found both inside hospital suites and operating rooms. Rptr is familiar with a case in which an oxygen flowmeter was forced into a nitrous oxide wall delivery system that was immediately adjacent to the oxygen wall delivery system. The "pin index system" was overidden since one of the oxygen flowmeter pins was broken at the time of insertion into the wall system. The other contributing factor to this error was that the task was performed in the dimmed light of a radiology (cat scan) suite and the respiratory tech did not distinguish purple (nitrous oxide) from green (oxygen). Sadly, the pt "resuscitated" with oxygen died of nitrous oxide poisoning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034291 |
| MDR Report Key | 565953 |
| Date Received | 2005-01-05 |
| Date Added to Maude | 2005-01-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN |
| Generic Name | OXYGEN |
| Product Code | CCN |
| Date Received | 2005-01-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555741 |
| Manufacturer | NOT GIVEN |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-01-05 |