MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-08 for MEDICAL FITTING FLOW SELECTOR MF8025 * manufactured by Precision Medical, Inc..
[192980]
Oxygen splitter device failed to switch to appropriate outlet for nasal o2. Switch mechanism caught halfway between outlets. Pt was not receiving oxygen as ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018409 |
| MDR Report Key | 269626 |
| Date Received | 2000-03-08 |
| Date of Report | 2000-03-08 |
| Date of Event | 1999-12-01 |
| Date Added to Maude | 2000-03-20 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 | MEDICAL FITTING FLOW SELECTOR |
| Generic Name | OXYGEN-FLOW SELECTOR |
| Product Code | CCN |
| Date Received | 2000-03-08 |
| Model Number | MF8025 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 261029 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-08 |