MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-08-25 for STAN FETAL HEART MONITOR UNKNOWN manufactured by Neoventa Medical Ab.
[16116877]
A number of different circumstances appear to be the root cause. The device appears to have indicated a pathological ctg (fhr) pattern, which was not managed according to the guidelines. There are no specific alarms for the pathological ctg only the tracing pattern. The following issues regarding lack of quality and patient safety were identified by (b)(6): organization, workload and authorities. Individual responsibility for pt. Absence of warnings for pathological ctg in the stan device. Limited knowledge of intrauterine pressure transducers. The device remains at the hospital. The hospital has not contacted neoventa regarding this case. The device is not considered the root cause, and neoventa has not had access to it. It is unclear if the stan s21 or s31 was used. Although, the initial reportability decision indicated that this was not a reportable event in the united states, in response to the fda warning letter of 08/04/2010, 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
[16166778]
Neoventa medical ab received an info copy of a decision report from (b)(6) board of health and welfare on 12/17/2008. The report, dated 12/11/2008, dnr (b)(4)2008 reported the death of a newborn fetus due to a number of very difficult circumstances during the labor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004729605-2010-00007 |
| MDR Report Key | 1819698 |
| Report Source | 00 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-08-19 |
| Date of Event | 2008-03-18 |
| Date Mfgr Received | 2008-12-17 |
| 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, MED 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 FETAL HEART MONITOR |
| Generic Name | HEO: OBSTETRIC DATA ANALYZER |
| Product Code | HEO |
| Date Received | 2010-08-25 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| 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 | 2010-08-25 |