MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-13 for FLOW SELECTOR PM1000 manufactured by Precision Medical, Inc..
[11378]
The rptr stated that the device has an inherent design problem. When changing the flow to the barb connector, the flow of oxygen ceases through the threaded outlet. If an oxygen-dependent pt who was receiving a treatment with a nebulizer put the nebulizer down, or if the nurse or therapist forgot to change the flow selector back, the pt would not get any oxygen. The rptr stated that pts have experienced respiratory distress but the problem was identified and corrected without any apparent injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005571 |
| MDR Report Key | 21134 |
| Date Received | 1995-04-13 |
| Date of Report | 1995-03-28 |
| Date Added to Maude | 1995-04-14 |
| 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 | FLOW SELECTOR |
| Generic Name | FLOW SELECTOR |
| Product Code | CCN |
| Date Received | 1995-04-13 |
| Model Number | PM1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 21108 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | NORTHAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1995-04-13 |