MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-14 for CAREFUSION VITAL SIGNS PRESSURE INFUSOR manufactured by Carefusion.
[60349074]
Pressure bags set up and inflated to maintain pressure, but bags kept deflating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066067 |
| MDR Report Key | 6105986 |
| Date Received | 2016-11-14 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-11-12 |
| Date Added to Maude | 2016-11-16 |
| 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 |
| 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 | 0 |
| Brand Name | CAREFUSION VITAL SIGNS PRESSURE INFUSOR |
| Generic Name | PRESSURE BAG |
| Product Code | KZD |
| Date Received | 2016-11-14 |
| Lot Number | 160193 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |