MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-21 for PRECISION MEDICAL FLOW SELECTOR UNK * manufactured by Precision Medical.
[21610566]
After transport of pt, rn connected o2 tubing to the flow selector connector port most prominent and closest to her. Approx. 45 mins. Later, o2 tubing found to be connected to closed port of flow selector, not port opened to o2 flow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 567743 |
| MDR Report Key | 567743 |
| Date Received | 2005-01-21 |
| Date of Report | 2005-01-21 |
| Date of Event | 2004-11-27 |
| Date Facility Aware | 2004-11-27 |
| Report Date | 2005-01-21 |
| Date Reported to FDA | 2005-01-21 |
| Date Reported to Mfgr | 2005-01-21 |
| Date Added to Maude | 2005-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL FLOW SELECTOR |
| Generic Name | FLOW SELECTOR |
| Product Code | BXY |
| Date Received | 2005-01-21 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 557571 |
| Manufacturer | PRECISION MEDICAL |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-01-21 |