MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-02 for 370 L LIQ N2O EXCELLOR manufactured by Allgas.
[24096]
Pt undergoing ambulatory procedure under nerve block. Nitrous oxide flow meter was turned on to provide supplemental anesthesia and pt immediately became agitated and began hyperventilating. End-tidal co2 identified sudden rise on co2 content. Pt given immediate o2 by face mask and values became normal. Immediate investigation identified suspect tank labelled nitrous oxide. Immediately disconnected, replaced with reserve tank, (after testing) and disabled top prevent possibility of further use. Entire facility medical gas system subsequently purged. Pt did fine but kept overnight for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35300 |
| MDR Report Key | 35300 |
| Date Received | 1996-07-02 |
| Date of Report | 1996-06-29 |
| Report Date | 1996-06-29 |
| Date Added to Maude | 1996-08-16 |
| 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 |
| 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 | 370 L LIQ N2O EXCELLOR |
| Generic Name | CRYOGENIC NITROUS OXIDE VESSEL ("DEWAR") |
| Product Code | CBR |
| Date Received | 1996-07-02 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 14342 |
| Manufacturer | ALLGAS |
| Manufacturer Address | 3150 MAIN ST HARTFORD CT 06120 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-02 |