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 |