MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-08-20 for MASTERSCOPE PFT OXYCON ALPHA 001-143710 manufactured by Sensormedics.
| Report Number | 2050001-2004-00028 |
| MDR Report Key | 897740 |
| Report Source | 05,07 |
| Date Received | 2004-08-20 |
| Date of Report | 2004-08-20 |
| Date of Event | 2004-07-29 |
| Date Mfgr Received | 2004-07-29 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2007-08-17 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS YORK |
| Manufacturer Street | 22705 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7142832228 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASTERSCOPE PFT |
| Generic Name | RESPIRATORY DIAGNOSTIC |
| Product Code | BZM |
| Date Received | 2004-08-20 |
| Model Number | OXYCON ALPHA |
| Catalog Number | 001-143710 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 874490 |
| Manufacturer | SENSORMEDICS |
| Manufacturer Address | * YORBA LINDA CA 928874645 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-08-20 |