MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-17 for AIRLIFE 001800 manufactured by Carefusion 211.
[1913583]
During a pulmonary function test, albuterol was being administered through a one-way valve. During the inhalation, the soft movable piece of the valve separated from the device and was inhaled by the patient. Patient complained of initial discomfort but an attempt to recover the valve material through bronchoscopy was unsuccessful. Patient regained a feeling of normalcy, possibly having coughed up and swallowed the material. ====================== manufacturer response for one-way valve, airlife======================none as yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025209 |
| MDR Report Key | 2025209 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-03-17 |
| Date of Event | 2011-03-03 |
| Report Date | 2011-03-17 |
| Date Reported to FDA | 2011-03-17 |
| Date Added to Maude | 2011-03-21 |
| 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 | AIRLIFE |
| Generic Name | ONE-WAY VALVE |
| Product Code | CBP |
| Date Received | 2011-03-17 |
| Model Number | 001800 |
| Catalog Number | 001800 |
| Lot Number | Y10S0086 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 211 |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-17 |