MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for CAREFUSION PEDIATRIC RESUSCITATION BAG manufactured by Carefusion 2200, Inc..
[176585387]
We had a pediatric bag fail on us in the emergency room. Crna's were intubating an (b)(6) male patient. After they tubed the child they could not get chest rise with bagging. The pop off valve seemed to be defective. Rt got them another pediatric bag and it worked just fine. The problem was quickly identified and no harm was done to the patient. The bag was taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9636279 |
| MDR Report Key | 9636279 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-11-26 |
| Report Date | 2020-01-09 |
| Date Reported to FDA | 2020-01-09 |
| Date Reported to Mfgr | 2020-01-28 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREFUSION PEDIATRIC RESUSCITATION BAG |
| Generic Name | PULMONARY RESUSCITATOR, MANUAL, REUSABLE |
| Product Code | BTM |
| Date Received | 2020-01-28 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-28 |