MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-04-26 for MEDICAL FITTINGS FLOW SELECTOR MF8025 * manufactured by Precision Medical, Inc..
[21634260]
It was reported that the "oxygen splitter" device failed to switch to appropriate outlet for nasal oxygen. Switch mechanism caught halfway between outlets. Pt was not receiving oxygen as ordered. Device as described by rptr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2000-00002 |
| MDR Report Key | 275930 |
| Report Source | 05,06 |
| Date Received | 2000-04-26 |
| Date of Report | 2000-04-24 |
| Date Mfgr Received | 2000-04-04 |
| Date Added to Maude | 2000-05-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CONLEY WALLACE |
| Manufacturer Street | 300 HELD DR |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL FITTINGS FLOW SELECTOR |
| Generic Name | OXYGEN FLOW SELECTOR |
| Product Code | BXY |
| Date Received | 2000-04-26 |
| Model Number | MF8025 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 267077 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US |
| Baseline Brand Name | MEDICAL FITTINGS FLOW SELECTOR |
| Baseline Generic Name | OXYGEN FLOW SELECTOR |
| Baseline Model No | MF8025 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-26 |