MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-27 for AIRLIFE 001268 manufactured by Carefusion 2200, Inc..
[65940566]
Patient Sequence No: 1, Text Type: N, H10
[65940567]
Anesthesia removed bag from pediatric oxygen mask to attach oxygen tubing directly. Small phlange/disk on mask came loose, potential choking hazard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6282480 |
| MDR Report Key | 6282480 |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-17 |
| Date of Event | 2017-01-06 |
| Report Date | 2017-01-17 |
| Date Reported to FDA | 2017-01-17 |
| Date Reported to Mfgr | 2017-01-17 |
| Date Added to Maude | 2017-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE |
| Generic Name | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) |
| Product Code | CCQ |
| Date Received | 2017-01-27 |
| Catalog Number | 001268 |
| Lot Number | 0000999487 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-27 |