MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-01 for MEDICAL GAS FLOW METER F56-210D2 * manufactured by Flotec, Inc..
[310569]
After disconnecting the oxygen flow meter to record the flow rate, the respiratory therapist was attempting to reconnect the meter to the oxygen wall outlet, a jet of water sprayed the therapist in the face. The water came from the humidifier because the flowmeter delivered a sudden burst of gas when the flowmeter was plugged into the wall. The humidifier was connected to the flow meter prior to the pulgging into the wall. The flowmeter was the problem. They cannot find a consistent condition that caused the flowmeter to do this. If the flowmeter is set to zero flow when plugged -in then adjusted to deliver oxygen flowrate, the flowmeter doesn't seem to fail. The wall outlet was find. No water reached the pt. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 510440 |
| MDR Report Key | 510440 |
| Date Received | 2003-12-01 |
| Date of Report | 2003-12-01 |
| Date of Event | 2003-12-01 |
| Date Added to Maude | 2004-02-10 |
| 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 | MEDICAL GAS FLOW METER |
| Generic Name | GAS FLOW METER |
| Product Code | CCN |
| Date Received | 2003-12-01 |
| Model Number | F56-210D2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 499390 |
| Manufacturer | FLOTEC, INC. |
| Manufacturer Address | 7625 W NEW YORK ST INDIANAPOLIS IN 462144911 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-01 |