MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-07-23 for STAN S31 FETAL HEART MONITOR SYS101003 manufactured by Neoventa Medical Ab.
[19799052]
The system is intermittently shutting down which is causing inconvenience.
Patient Sequence No: 1, Text Type: D, B5
[19858736]
The system is intermittently shutting down which is causing inconvenience. Awaiting the device for further investigation. No harm to pt reported and no add'l treatment needed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2014-00002 |
| MDR Report Key | 3994432 |
| Report Source | 00 |
| Date Received | 2014-07-23 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-03-05 |
| Date Mfgr Received | 2014-04-08 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2014-08-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JONSSON |
| Manufacturer Street | NORRA AGATAN 32 |
| Manufacturer City | MOEINDAL 43135 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43135 |
| Manufacturer Phone | 17583200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAN S31 FETAL HEART MONITOR |
| Generic Name | HEO: OBSTETRIC DATA ANALYZER |
| Product Code | HEO |
| Date Received | 2014-07-23 |
| Model Number | STAN S31 |
| Catalog Number | SYS101003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOVENTA MEDICAL AB |
| Manufacturer Address | MOEINDAL SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-23 |