MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-01-11 for STAN S31 FETAL HEART MONITOR STAN S31 SYSTEM SYS101003 manufactured by Neoventa Medical Ab.
[3369959]
Baby monitored with efm and st analysis from 08. 00 am. Oxytocin infusion ongoing, maternal temp 38. 2c. Fetal blood sampling ph (b)(6) at 08. 45 am. Delivery terminated at 11. 06 am with midcavity vacuum extraction, (b)(6). Baby resuscitated for 30 minutes, no cord blood gases available. First ph at arrival at neonatal unit: 6. 30. Antibiotics given to baby prior to blood culture: negative for mother and baby. Baby died at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[10451378]
The incident was reported to neoventa office in (b)(6). The device remains in the hospital and no failure to the device has been reported. There is no obvious cause of the outcome in the efm recording. There are no cord gases available until the arrival to the neonatal unit after more than 30 min of resuscitation: ph (b)(6) the obstetric team performed correctly according to guidelines. Suspicion of infection due to high crp values, as antibiotics was administered to baby prior to blood culture. The parents have denied post-mortem examination.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2013-00001 |
| MDR Report Key | 2917301 |
| Report Source | 05,06,07 |
| Date Received | 2013-01-11 |
| Date of Report | 2013-10-01 |
| Date of Event | 2012-12-02 |
| Date Mfgr Received | 2012-12-11 |
| Date Added to Maude | 2013-01-16 |
| 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 Contact | MARIA GRANBERG, DIR. |
| Manufacturer Street | AGATAN 32 |
| Manufacturer City | MOEINDAL SE-431 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-431 |
| 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 | 2013-01-11 |
| Model Number | STAN S31 SYSTEM |
| 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 | 1. Death | 2013-01-11 |