MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-04-04 for STAN S31 FETAL HEART MONITOR SYS101003 manufactured by Neoventa Medical Ab.
[16778365]
According to the incident report, during the last 12 minutes of the critical delivery, it has not been possible to assess and document the heart rate of the unborn child. No injury to the baby was reported. The customer has been contacted regarding additional info and investigation initiated.
Patient Sequence No: 1, Text Type: D, B5
[16941086]
The event was reported by the customer to the danish hlth and medicines agency who informed neoventa medical (b)(4). The report was not received directly from the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2014-00001 |
| MDR Report Key | 3853284 |
| Report Source | 00 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-04-03 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-06-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JOHNSON |
| Manufacturer Street | NORRA AGATAN 32 |
| Manufacturer City | MOLNDAL 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 | 2014-04-04 |
| Model Number | STAN S31 |
| Catalog Number | SYS101003 |
| Lot Number | NA |
| 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 | 2014-04-04 |