MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-21 for SELECT FLOWMETER OHMEDA 3MFA1005 manufactured by Precision Medical.
[1396231]
Flowmeter had a crack in its base which was not easily visible, but a modest weight (e. G. , humidifier) attached was enough to spread the crack and cause leakage. The flowmeter indicated proper flow, but very little of it entered the humidifier to the patient. When the problem was discovered and the flowmeter was replaced, the result was "noticeable improvement" in the patient's o2 saturation. ======================health professional's impression======================physical damage was already visible on the flowmeter when it was put in use. Most of one hose barb and a 2-cm portion of the base were broken off. Attempted use of the obviously damaged flowmeter led to the problem of the leaking crack and inadequate oxygenation of the patient, which may have been avoided if the flowmeter had been reported and sent for testing after it was damaged. ======================manufacturer response for oxygen flowmeter, select======================mfr was given details and photographs, and did not think it was necessary to have flowmeter sent to them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1710460 |
| MDR Report Key | 1710460 |
| Date Received | 2010-05-21 |
| Date of Report | 2010-05-13 |
| Date of Event | 2010-05-12 |
| Report Date | 2010-05-13 |
| Date Reported to FDA | 2010-05-21 |
| Date Added to Maude | 2010-06-04 |
| 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 | 0 |
| 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 | SELECT FLOWMETER |
| Generic Name | FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED |
| Product Code | CAX |
| Date Received | 2010-05-21 |
| Model Number | OHMEDA |
| Catalog Number | 3MFA1005 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-21 |