MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-08-25 for STAN S31 FETAL HEART MONITOR STAN S31 SYSTEM SYS101003 manufactured by Neoventa Medical Ab.
[21993631]
Additional info from the voluntary report: case report: (b)(6). The case does not represent a typical complaint. No customer or responsible clinician has approached neoventa complaining of an unexpected behaviour of stan. The case has become known to neoventa employees (b)(4). Neoventa's medical advisor, (b)(4) (not employed in neoventa) got aware of the case in (b)(4) 2007 (more than one year after the incident) when the hospital approached him with a request to analyze the recordings of the case. Training has been performed first by three users from the clinic visiting the neoventa office 2003. Afterwards continuous internal training at clinic has been performed. Our conclusion is that: there was no deficiency on the stan monitor; the stan simplified clinical guidelines were not followed, as they recommend immediate delivery in the presence of a preterminal trace. The problem may be posed in clinical practice, with the assessment and classification of the fhr trace. This report is classified as final. Investigation has been completed and root cause has been determined, to the extent possible.
Patient Sequence No: 1, Text Type: N, H10
[22232304]
The stan clinical guidelines were not followed in the presence of an abnormal ctg. The tracing was preterminal and immediate delivery was recommended per the guidelines. The baby was delivered in serious condition. Additional info: event in (b)(6). Date of incident: 2006-(b)(6). Neoventa got aware: 2007-(b)(6). Serious injury for pt (baby). User error; the stan clinical guidelines were not followed, as they recommend immediate delivery in the presence of a "preterminal" trace. Add'l info from vol report: pt monitoring system, cardiographic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004729605-2010-00003 |
| MDR Report Key | 1886196 |
| Report Source | 01,05 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-08-23 |
| Date of Event | 2006-03-02 |
| Date Mfgr Received | 2007-10-15 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2010-11-08 |
| 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 | 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 | 2010-08-25 |
| Model Number | STAN S31 SYSTEM |
| Catalog Number | SYS101003 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2010-08-25 |