MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-06 for EASYPULSE 5 OXYGEN CONSERVANT REGULATOR * manufactured by Physician Medical Company.
[669717]
Pt states that her daughter was in the process of changing her oxygen bag when the device exploded and flames were extinguished by turning off the machine with it's key. Her daughter sustained a first degree hand burn. The explosion was preceded by a loud "pop" sound. Unsure what caused the flames to arise. She denies being ignited by an outside source (ie. Smoking, etc). Daughter's hand was ok. They immediately called 911 and an ambulance was dispensed. Supplier contacted and states that this has been known to occur every 3 months. Consumer feels product needs to be removed from the market.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002482 |
| MDR Report Key | 861417 |
| Date Received | 2007-06-06 |
| Date of Report | 2007-06-06 |
| Date of Event | 2007-06-03 |
| Date Added to Maude | 2007-06-07 |
| 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 | EASYPULSE 5 OXYGEN CONSERVANT REGULATOR |
| Generic Name | OXYGEN TANK/DISPENSER |
| Product Code | NFB |
| Date Received | 2007-06-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 844513 |
| Manufacturer | PHYSICIAN MEDICAL COMPANY |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-06 |