MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-16 for LIFEGAS, 21% O2 / 79% N2 11932 manufactured by Lifegas.
[1596209]
Data to be submitted to medwatch via fax. Event abated after use: #1 & #2. No. Event reappeared after reintroduction: #1 & #2. No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016783 |
| MDR Report Key | 1766927 |
| Date Received | 2010-07-16 |
| Date of Report | 2010-07-16 |
| Date of Event | 2009-11-13 |
| Date Added to Maude | 2010-07-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEGAS, 21% O2 / 79% N2 |
| Generic Name | LIFEGAS / LINDE SPECIALTY GAS |
| Product Code | BXK |
| Date Received | 2010-07-16 |
| Returned To Mfg | 2009-11-20 |
| Catalog Number | 11932 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFEGAS |
| Manufacturer Address | 7029 HUNTLEY RD COLUMBUS OH 43229 US 43229 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-16 |