MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-07 for PRECISION MEDICAL AMFA 1001 * manufactured by Precision Medical.
[360194]
Rn noted pt o2 sats dropping to 88%. She traced o2 tubing back to flow meter and noted low flow meter in use at. 2lpm. Meter changed and rate set at 1lpm with improved o2 sats. Pt received x-rays as result of incorrect info. These flow meters had been pulled due to difficulty seeing the decimal point; however, this one was still in circulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032543 |
| MDR Report Key | 540887 |
| Date Received | 2004-07-07 |
| Date of Report | 2004-06-30 |
| Date of Event | 2004-04-19 |
| Date Added to Maude | 2004-08-30 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | PRECISION MEDICAL |
| Generic Name | WALL O2 LOW FLOW METER |
| Product Code | CCN |
| Date Received | 2004-07-07 |
| Model Number | AMFA 1001 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 530218 |
| Manufacturer | PRECISION MEDICAL |
| Manufacturer Address | 300 HELD DR NORTHAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-07 |