MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-08-25 for STAN S 31 FETAL HEART MONITOR STAN S31 ART. NO SYS101003 manufactured by Neoventa Medical Ab.
[1350306]
The fetal heart rate and st registration was poor during labor. The staff disabled the st function during parts of labor, which is not a recommended action. The baby was born with low apgar, was resuscitated and transferred to nicu. At follow-up in (b)(6) 2010, brain mr shows ischemia and the baby shows signs of permanent damage.
Patient Sequence No: 1, Text Type: D, B5
[8721951]
Digital fekg data have been analyzed and contain extremely high p-waves. It's not clear if this is part of the root cause of the incident. But fekg appearance and partly some signal interference have contributed to the low quality of ctg and st-curve analysis. The operator turned off the st analysis function despite that this is not a recommended action. The analysis of data shows that st events would have appeared approx. 1 hour before delivery, unless the function had been turned off. However, it's unclear whether this had affected the outcome. Neoventa requested the pib for further technical analysis. On (b)(6)2009 pib arrived at neoventa. Investigation by technical support shows that it works according to specifications. This was communicated to the bio. Med at (b)(6) hospital on (b)(6)2010. Detailed investigation has been made in terms of both signal quality and current hardware and includes more detailed info. Corrective action: it is stressed that the cleaning instructions for leg plate and skin electrode connection must be followed. The device functioned according to specifications. There were unusually large fekg complexes. This contributed to poorer coverage of the fhr, but enough to interpret the fhr curve. The operator disabled the st analysis approx 1. 5 hours before delivery. The reason is unk. When st is disabled, the operator is warned that st function will no longer function. The customer confirms there's been no problems with signal quality since implementation of the recommended cleaning instructions. The initial reportability decision indicated this was not a reportable event in the u. S. , (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2010-00009 |
| MDR Report Key | 1819778 |
| Report Source | 01,05,06 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-08-25 |
| Date of Event | 2009-10-26 |
| Date Mfgr Received | 2009-11-02 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2010-09-02 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 S 31 FETAL HEART MONITOR |
| Generic Name | HEO: OBSTETRIC DATA ANALYZER |
| Product Code | HEO |
| Date Received | 2010-08-25 |
| Returned To Mfg | 2009-11-13 |
| Model Number | STAN S31 |
| Catalog Number | ART. NO SYS101003 |
| Lot Number | NA |
| ID Number | SW R3B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2010-08-25 |