MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-29 for OHMEDA * manufactured by Ohio Medical Corporation.
[19675358]
During normal nasal cannula check, found no bubbling in the humidifier. Checked flowmeter, ball at liter-per-minute; when flow turned up, bubbling increased. Then tried to turn flowmeter off; ball would not decrease to zero. Found that flowmeter had small crack in the flow tube assembly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2354310 |
| MDR Report Key | 2354310 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-10-30 |
| Report Date | 2011-11-29 |
| Date Reported to FDA | 2011-11-29 |
| Date Added to Maude | 2011-12-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | OHMEDA |
| Generic Name | FLOWMETER, OXYGEN |
| Product Code | CAX |
| Date Received | 2011-11-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-29 |