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 manufactured by Neoventa Medical Ab.
[17528509]
There was no death or serious injury, but the baby was born with low apgar scores (b)(6) 2009, and metabolic acidosis according to cord gases (art ph 6. 75 vein ph 6. 82), needed resuscitation and was transferred to (b)(6). Despite a deteriorating fetal heart rate tracing and st events, the provider continued labor for 60 minutes before performing a c/s.
Patient Sequence No: 1, Text Type: D, B5
[17657099]
We conclude that the event is retrospectively reportable to the fda in accordance with (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2010-00010 |
| MDR Report Key | 1819959 |
| Report Source | 08 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-08-20 |
| Date of Event | 2009-11-21 |
| Date Mfgr Received | 2009-11-30 |
| 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, 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 | 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 |
| 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. Required No Informationntervention | 2010-08-25 |