MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-04 for * manufactured by Luxfer Cylinder.
[669646]
Caregiver of pt, (pt's husband) was replacing an empty oxygen usp medical "e" style cylinder with a new full cylinder. The caregiver attached the regulator to the new cylinder and when he opened the cylinder valve there was brief fire flash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002483 |
| MDR Report Key | 863247 |
| Date Received | 2007-06-04 |
| Date of Report | 2007-06-04 |
| Date of Event | 2007-05-04 |
| Date Added to Maude | 2007-06-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | OXYGEN CYLINDER WITH VALVE AND REGULATOR |
| Product Code | ECX |
| Date Received | 2007-06-04 |
| Returned To Mfg | 2007-05-04 |
| Lot Number | 14606D7251AD |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 846506 |
| Manufacturer | LUXFER CYLINDER |
| Manufacturer Address | 3016 KANSAS AVE RIVERSIDE CA 92507 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-04 |