MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-29 for OXYGEN FLOWMETER WITH STANDARD INLET 1/2 TO 15 LPM * FME101 manufactured by Western Medica.
[3715082]
Two problems reported with flowmeter. First, the ball of the flowmeter stuck to the top of the flow tube. Second, the users were not aware of the maximum flow the flowmeter was capable of providing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3357040 |
| MDR Report Key | 3357040 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-08-29 |
| Date of Event | 2013-08-27 |
| Report Date | 2013-08-29 |
| Date Reported to FDA | 2013-08-29 |
| Date Reported to Mfgr | 2013-09-19 |
| Date Added to Maude | 2013-09-19 |
| 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 | 3 |
| 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 | OXYGEN FLOWMETER WITH STANDARD INLET 1/2 TO 15 LPM |
| Generic Name | FLOWMETER, CALIBRATION, GAS, OXYGEN |
| Product Code | CAX |
| Date Received | 2013-08-29 |
| Model Number | * |
| Catalog Number | FME101 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTERN MEDICA |
| Manufacturer Address | 875 BASSETT RD. WESTLAKE OH 44145 US 44145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-29 |