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.
[16593405]
While using mapleson bag the green bag piece completely detached from the white plastic adapter. Large pressures were not being used. Operator initiated breaths on 90% fio2 used on servo vent while a new bag was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034418 |
| MDR Report Key | 3628125 |
| Date Received | 2014-02-10 |
| Date of Report | 2014-02-07 |
| Date of Event | 2013-12-16 |
| 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 |
| 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 |