MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES manufactured by Epic Systems Corporation.
[119669429]
Only two of my frequent blood pressures pulled over, then the monitor disassociated and stopped pulling over the vitals. This is probably the 4th time this has happened lately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7859725 |
| MDR Report Key | 7859725 |
| Date Received | 2018-09-10 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-07-26 |
| Report Date | 2018-08-07 |
| Date Reported to FDA | 2018-08-07 |
| Date Reported to Mfgr | 2018-09-10 |
| Date Added to Maude | 2018-09-10 |
| 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 |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2018-09-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPIC SYSTEMS CORPORATION |
| Manufacturer Address | 1979 MILKY WAY VERONA WI 53593 US 53593 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-10 |