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.
[4202877]
While manually bagging pt during active desaturation episode, pt's mapleson bag fell apart where the green reservoir bag part is taped on to the white adapter piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034414 |
| MDR Report Key | 3628119 |
| Date Received | 2014-02-10 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-01-01 |
| 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 | 0000619017 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | VERNON HILL IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-10 |