MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-02-25 for OXYGEN ANALYZER OM25AE manufactured by Maxtec, Inc..
[15606026]
Infant patient was resting in a bassinet under an infant warmer with an oxygen hood in place. Oxygen hood was placed over the infant's head and was attached to an oxygen air blender for administration of 100% oxygen. As the staff approached the bassinet, they observed a flash of flames under the oxygen hood. Staff removed hood and removed oxygen from the wall. Staff used a blanket to extinguish the fire.
Patient Sequence No: 1, Text Type: D, B5
[15888896]
All information for this report is from user facility. Event was unknown to maxtec, until user facility faxed a copy of the mdr to us on 02/01/2008. The product has not been analyzed yet. Sales representative from maxtec, was allowed to view product and take pictures; in approximately two weeks maxtec engineers will be allowed to view product in user facility, and analyze product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722070-2008-00001 |
| MDR Report Key | 1003785 |
| Report Source | 99 |
| Date Received | 2008-02-25 |
| Date of Report | 2008-02-25 |
| Date of Event | 2008-01-22 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 2008-02-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBBIE MIRANDA |
| Manufacturer Street | 6526 SOUTH COTTONWOOD ST. |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal | 84107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN ANALYZER |
| Generic Name | OM25AE |
| Product Code | CCL |
| Date Received | 2008-02-25 |
| Model Number | OM25AE |
| Catalog Number | OM25AE |
| Lot Number | GC0228991 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 971830 |
| Manufacturer | MAXTEC, INC. |
| Manufacturer Address | 6526 SOUTH COTTONWOOD ST. SALT LAKE CITY UT 84107 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2008-02-25 |