MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-23 for MEDGRAPHICS PFDX DEMAND VALVE - G500 * manufactured by Medical Graphics Corporation.
[16264696]
During a complete pulmonary function test, the demand valve malfunctioned, allowing tank pressure to be delivered to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015286 |
| MDR Report Key | 203476 |
| Date Received | 1998-12-23 |
| Date of Report | 1998-11-09 |
| Date of Event | 1998-08-19 |
| Date Added to Maude | 1998-12-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDGRAPHICS PFDX |
| Generic Name | PULMONARY FUNCTION TEST EQUIPMENT |
| Product Code | BZM |
| Date Received | 1998-12-23 |
| Model Number | DEMAND VALVE - G500 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 197649 |
| Manufacturer | MEDICAL GRAPHICS CORPORATION |
| Manufacturer Address | 350 OAK GROVE PARKWAY ST. PAUL MN 551278599 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-23 |