MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-10 for 2K8027 manufactured by Carefusion.
[4202367]
The pt's mapleson bag came apart. The tape holding the green bag to connector came undone. Pt changed to hand ventilation with ambu bag. No decompensation with event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034411 |
| MDR Report Key | 3628057 |
| Date Received | 2014-02-10 |
| Date of Report | 2014-02-07 |
| Date of Event | 2013-11-29 |
| Date Added to Maude | 2014-02-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MAPLESON BAG |
| Product Code | KNE |
| Date Received | 2014-02-10 |
| Model Number | 2K8027 |
| Lot Number | 0000609407 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-10 |