MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-21 for AMVEX FM-04UO * manufactured by Ohio Medical Corporation.
[2353146]
Infant on. 03l of wall o2 via a pediatric flow meter, with a spo2 of 99-100%. Weaned to 21% o2 - wall o2 turned off. Discovered a mild - flow through nasal cannula while in off position. When placed in 21%, without nasal cannula, spo2 = 65%. Patient was immediately placed back on o2 to recover to spo2. Respiratory therapy notified; pediatric flow meter removed and replacement put in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2347846 |
| MDR Report Key | 2347846 |
| Date Received | 2011-11-21 |
| Date of Report | 2011-10-19 |
| Date of Event | 2011-10-02 |
| Report Date | 2011-10-19 |
| Date Reported to FDA | 2011-11-21 |
| Date Added to Maude | 2011-11-23 |
| 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 | AMVEX |
| Generic Name | FLOWMETER, PEDIATRIC, O2 |
| Product Code | CAX |
| Date Received | 2011-11-21 |
| Model Number | FM-04UO |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | 1111 LAKESIDE DR. GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-21 |