MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-12 for PURITAN SERIES C * manufactured by Covidien.
[1966608]
When the flowmeter was inserted into oxygen outlet in the wall, the top of the flowmeter popped off along with other small pieces and flew into the surrounding bed area. Our bio-tech staff estimate that it's at least 20 years old. After this incident, we gathered up the other flowmeters that were the same model and similar age. Of the four similar flowmeters that we found, two appeared to be fine, one from a different lot had cracks in the top "cap" and one from the same lot had a crack in the top "cap. "======================health professional's impression======================no adverse event to a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1981449 |
| MDR Report Key | 1981449 |
| Date Received | 2011-01-12 |
| Date of Report | 2011-01-12 |
| Date of Event | 2011-01-02 |
| Report Date | 2011-01-12 |
| Date Reported to FDA | 2011-01-12 |
| Date Added to Maude | 2011-02-08 |
| 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 | PURITAN |
| Generic Name | PRESSURE COMPENSATED FLOWMETER |
| Product Code | CAX |
| Date Received | 2011-01-12 |
| Model Number | SERIES C |
| Catalog Number | * |
| Lot Number | LOT CODE AAE |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 6135 GUNBARREL AVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-12 |