MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-08-25 for STAN S31 FETAL HEART MONITOR SYS101003 manufactured by Neoventa Medical Ab.
[1349301]
Distributor reported that during monitoring of a term labor, there was the onset of variable decelerations. The scalp ph was 7. 36 (normal). Stan monitoring continued without st analysis determined due to poor signal quality. The ctg became progressively worse, and there was a preterminal tracing prior to delivery. There was no earlier intervention and a dead baby was delivered by vacuum extraction.
Patient Sequence No: 1, Text Type: D, B5
[8720511]
The stan device was monitoring a term delivery with variable decelerations, scalp ph 7. 36 (normal). During the progress of labor, inadequate signal quality with no st info. Progressively worsening ctg and prior to delivery preterminal. Vacuum extraction is performed, but the baby is delivered dead. The event was reported to finnish authorities. In response to the fda warning letter of august 4, 2010, and capa project (b)(4), this event will be reported in the united states according to the table below. We are aware that reporting timelines cannot be met with the retrospective reporting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2010-00002 |
| MDR Report Key | 1819722 |
| Report Source | 08 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-08-20 |
| Date of Event | 2007-05-08 |
| Date Mfgr Received | 2007-06-18 |
| Date Added to Maude | 2010-08-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA GRANBERG, MEDICAL DIR. |
| Manufacturer Street | AGATAN 32 |
| Manufacturer City | MOLNDAL SE-431 35 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-431 35 |
| Manufacturer Phone | 17583200 |
| Single Use | 0 |
| 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 | 2010-08-25 |
| Model Number | SYS101003 |
| ID Number | 50270000165 |
| 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 | 2010-08-25 |