MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-06-25 for PRECISON MEDICAL COLOR CODED FLOWMETER 2MFA5008 manufactured by Precision Medical Inc..
[127221]
Preliminary investigation indicates that the flowmeter was used in conjunction with a liquid oxygen system in a nursing home setting. During treatment at the nursing home, the flow rate was apparently and without authorization reset to a level that allowed for oxygen flow in excess of the medically prescribed flow rate and in excess of a rate which could be, over time accommodated by the design of the oxygen delivery system. The resulting damage was frozed facial tissue of pt's lips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-1999-00006 |
| MDR Report Key | 230062 |
| Report Source | 00 |
| Date Received | 1999-06-25 |
| Date of Report | 1999-06-23 |
| Date of Event | 1998-08-21 |
| Date Mfgr Received | 1999-05-27 |
| Date Added to Maude | 1999-07-07 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISON MEDICAL COLOR CODED FLOWMETER |
| Generic Name | 20 PSI, 8 LPM, FLOWMETER |
| Product Code | BXY |
| Date Received | 1999-06-25 |
| Model Number | 2MFA5008 |
| Catalog Number | 2MFA5008 |
| Lot Number | 0297 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 223123 |
| Manufacturer | PRECISION MEDICAL INC. |
| Manufacturer Address | 300 HELD DR NORTHAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1999-06-25 |