MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-09-09 for STAN S31 FETAL HEART RATE MONITOR STAN S31/CTG SYS101003 manufactured by Neoventa Medical Ab.
[2654459]
Adverse event reported by the labor and delivery unit to (b)(6), (b)(6) with a copy to neoventa by mail. The event is described as a poor interpretation of fetal heart rate (ctg) resulting in a c/s with a baby born with apgar score 0,2,2. The baby was transferred to (b)(6) for further treatment. The device used for monitoring was a stan s31 ctg, including software with only fetal heart rate tracing and no st analysis of the fetal ecg.
Patient Sequence No: 1, Text Type: D, B5
[9850591]
The device was not returned to neoventa. In the report from the customer no device failure is described. Poor interpretation of fetal heart rate is a known problem in fetal monitoring. The device is in use in the hosp.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2010-00011 |
| MDR Report Key | 2571358 |
| Report Source | 05,06 |
| Date Received | 2010-09-09 |
| Date of Report | 2010-09-08 |
| Date of Event | 2010-04-09 |
| Date Mfgr Received | 2010-09-06 |
| Date Added to Maude | 2012-05-16 |
| 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, MEDICAL DIR. |
| Manufacturer Street | NORRA AGATAN 32 |
| Manufacturer City | MOLNDAL SE-431 35 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-431 35 |
| 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 | 2010-09-09 |
| Model Number | STAN S31/CTG |
| Catalog Number | SYS101003 |
| Lot Number | 0860030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOVENTA MEDICAL AB |
| Manufacturer Address | MOLNDAL SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2010-09-09 |