MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-08-24 for STAN S31 FETAL HEART MONITOR SYS101003 manufactured by Neoventa Medical Ab.
[1586025]
A neoventa medical (b)(6) employee heard about this case of a poor newborn outcome that has been reported to the medical board in (b)(6). The information was internally entered in the clinical feedback log.
Patient Sequence No: 1, Text Type: D, B5
[8752407]
The clinic has not provided detailed information regarding the case of device. The stan remains in the hospital. It is our understanding that they are treating this as a user error. We believe there are no failures with the device, and that the device is still in use. Neoventa believes that the device is not considered the root cause for the incident. Although the initial reportability decision indicated that this was not a reportable event in the us, in response to the fda warning letter of august 4, 2010, and capa project (b)(4), this event will be reported in the us 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 | 3004729605-2010-00004 |
| MDR Report Key | 1820013 |
| Report Source | 07 |
| Date Received | 2010-08-24 |
| Date of Report | 2010-08-19 |
| Date of Event | 2007-10-01 |
| Date Mfgr Received | 2007-12-04 |
| Date Added to Maude | 2012-03-12 |
| 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, DIR. |
| Manufacturer Street | 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 | 2010-08-24 |
| Model Number | SYS101003 |
| Lot Number | P0490819 OR P0460811 |
| 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. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2010-08-24 |