MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-04 for OXYMATIC OXYGEN CONSERVING DEVICE 411A * manufactured by Chad Therapeutics, Inc..
[613410]
Home care patient who has been on oxygen for 5 years. Very compliant. Oxygen supplied by contracted services. Patient was switching oxygen conserver from e tank to b tank. Saw flame, heard loud noise. Blackened soot area to right forehead and left palm. No burns. Patient and wife very upset. Patient complained tenderness to same two areas noted above.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042471 |
| MDR Report Key | 834992 |
| Date Received | 2007-04-04 |
| Date of Report | 2007-03-29 |
| Date of Event | 2007-03-27 |
| Date Added to Maude | 2007-04-09 |
| 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 | 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 | OXYMATIC OXYGEN CONSERVING DEVICE |
| Generic Name | * |
| Product Code | NFB |
| Date Received | 2007-04-04 |
| Returned To Mfg | 2007-03-27 |
| Model Number | 411A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 822315 |
| Manufacturer | CHAD THERAPEUTICS, INC. |
| Manufacturer Address | 21622 PLUMMER ST. CHATSWORTH CA 91311 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-04 |