MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-09 for STAN S31 FETAL HEART RATE MONITOR manufactured by Neoventa Medical Ab.
[20929316]
A baby monitored with stan s31 was born with metabolic acidosis defined by umbilical cord arterial blood sample. A first review of the case indicated that the labor was allowed to continue too long with non-reassuring fetal heart rate (fhr), which is in clear violation of the stan s31 guidelines. There are currently no indication for malfunction in the device, neither faulty labelling nor weakness in methodology. Neoventa has trained the clinicians at the hosp. A f/u report will be submitted as soon as a more thorough investigation has been completed. Newborn was discharged from the hosp alive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004729605-2008-00001 |
| MDR Report Key | 1359066 |
| Report Source | 05 |
| Date Received | 2009-04-09 |
| Date of Report | 2008-10-09 |
| Date of Event | 2008-01-10 |
| Date Mfgr Received | 2008-09-16 |
| Date Added to Maude | 2009-04-16 |
| 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 Street | AGATAN 32 |
| Manufacturer City | MOEINDAL SE-431-35 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-431-35 |
| Manufacturer Phone | 17583200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAN S31 FETAL HEART RATE MONITOR |
| Generic Name | HEO: OBSTETRIC DATA ANALYZER |
| Product Code | HEO |
| Date Received | 2009-04-09 |
| Model Number | STAN S31 |
| Catalog Number | STAN S31 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-09 |