MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-02-10 for STAN S31 FETAL HEART MONITOR STAN S31 SYSTEM SYS101003 manufactured by Neoventa Medical Ab.
[1903577]
Stillborn baby monitored with stan s31 during labor. Apgar 0/0/0. The team was not able to resuscitate. Autopsy will be performed. Ph 7. 18 from one cord vessel after birth.
Patient Sequence No: 1, Text Type: D, B5
[8863406]
The incident was reported to neoventa by the (b)(4) distributor approx one month after the incident took place. The exact date is unk. To our knowledge the stan device remains in the hosp and no failure of the device has been reported. The ph of 7. 18 from one cord vessel after birth does not indicate that the event is related to oxygen deficiency and/or to the surveillance of the fetus with stan s31 during labor. Neoventa believes that the device is not considered the root cause of the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2011-00001 |
| MDR Report Key | 1990251 |
| Report Source | 08 |
| Date Received | 2011-02-10 |
| Date of Report | 2011-02-10 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-02-09 |
| Date Added to Maude | 2011-02-15 |
| 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 |
| 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 | 2011-02-10 |
| 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 | MOLNDAL SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-02-10 |