MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-13 for FLOW SENSOR 1503-3244-000 * manufactured by Datex Ohmeda.
[15747077]
The hospital incident report states: that when the ventilator was turned on, a message appeared stating "vent fail- inspiratory flow sensor and replace inspiratory flow sensor... To get ventilation to work, flip switch to bag mode and switch back. " as reported to biomed, the ventilator was not tested before the case and the flow sensors had been replaced the night before with the newer, metallic tube style, sensors. The flow sensor unit was replaced and ventilation began normally after that. The flow sensor assembly was brought to the biomed dept for more testing and installed in the backup machine. Immediately upon turning on the machine, a "insp flow sensor fail" message appeared. The sensor assembly was removed and re-calibrated with same result. Error messages duplicate the ones reported in the ir, incident report. There was no visible damage or moisture. Staff responded correctly by replacing the flow sensor assembly and filing an incident report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 550244 |
| MDR Report Key | 550244 |
| Date Received | 2004-10-13 |
| Date of Report | 2004-10-13 |
| Date of Event | 2004-10-12 |
| Report Date | 2004-10-13 |
| Date Reported to FDA | 2004-10-13 |
| Date Added to Maude | 2004-10-22 |
| 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 | FLOW SENSOR |
| Generic Name | AUTOCLAVABLE TYPE |
| Product Code | BXY |
| Date Received | 2004-10-13 |
| Model Number | 1503-3244-000 |
| Catalog Number | * |
| Lot Number | AE0730 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 539758 |
| Manufacturer | DATEX OHMEDA |
| Manufacturer Address | PO BOX 7550 MADISON WI 53707 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-13 |