MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for VITAL SIGNS IN900012 manufactured by Carefusion.
[66063096]
Patient Sequence No: 1, Text Type: N, H10
[66063097]
Using a pressure bag for saline flush during arterial access for cerebral angiogram. Pressure bag failed. Was initially inflated at start of procedure and when we tried to re-inflate it as fluid had been used. It would not inflate and was losing pressure.
Patient Sequence No: 1, Text Type: D, B5
[71409391]
Patient Sequence No: 1, Text Type: N, H10
[71409392]
Using a pressure bag for saline flush during arterial access for cerebral angiogram. Pressure bag failed. Was initially inflated at start of procedure and when we tried to re-inflate it as fluid had been used. It would not inflate and was losing pressure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6285507 |
| MDR Report Key | 6285507 |
| Date Received | 2017-01-30 |
| Date of Report | 2017-01-27 |
| Date of Event | 2017-01-18 |
| Report Date | 2017-01-27 |
| Date Reported to FDA | 2017-01-27 |
| Date Reported to Mfgr | 2017-01-27 |
| Date Added to Maude | 2017-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | VITAL SIGNS |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-01-30 |
| Model Number | IN900012 |
| Catalog Number | IN900012 |
| Lot Number | 162787 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY SUITE A YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-30 |