MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,08 report with the FDA on 2010-05-27 for STAN S31 FETAL HEART MONITOR ART. NO SYS101003 manufactured by Neoventa Medical Ab.
[1504867]
The initial rptr sent a digital copy of a recording to neoventa, together with some background info, and the following question: "time 15:12, the baseline of the heart frequency declines for 4 minutes and the fecg complex is not recorded at all - the decision of the emergency-section is made. The result: perfect baby was born - that is good! (ph from the umbilical cord was 7,31) (the baby was examined carefully later in order to eliminate the possible heart diseases. Nothing showed up - luckily. ) the scalp electrode was firmly attached even after the baby was born. Noticed that there was same kind of deceleration (shorter - though) at 12:53 o'clock. The signal quality seemed to be poor in both situations, and no t/qrs ratios were shown at that time either. My questions are: is it possible that the system software could have caused the deceleration? Could there be any effect (sort of interference) if the toco transducer is laid beside the mother - not registrating the contractions at that time? " the examination of the digital stan device tracing suggests that the skin electrode was loose (see blue field in figure above) and therefore, no correct recording of fetal heart rate or st info could be performed by the stan device. The situation occurred when the pt was placed on the side for an epidural anesthesia placement. It may indicate that the pt was in pain, resulting in sweating, moist skin and the loosening skin electrode.
Patient Sequence No: 1, Text Type: D, B5
[8546673]
Eval summary: the device itself has not yet been evaluated, but digital data from the recording was submitted as part of initial report. Based on this data, which also includes impedance values from electrodes, the conclusion is drawn that skin electrode was most likely loose that last 4 minutes of the recording. It can be seen from digital data, that during this period, the system appears to have picked up some sort of periodic signal interference in the spiral-to-scalp lead, with an amplitude four times stronger than the baby's qrs amplitude, interference to the right, fetal ecg qrs-complex to the left. This type of raw data segment are only stored once every five minutes, and therefore, only one of these peaks are identified during the four-minute interference. This most likely caused the fhr detection algorithm to stop trigging on the baby qrs, and started to present an fhr trace based on this stronger signal instead. (similar behaviour was actually seen for about 30 seconds earlier in the recording as well, when the skin electrode also became loose. ) the source for this interference has not been possible to identify. As the digital data shows very good signal quality and performance apart from the periods of high electrode impedance, the device is considered to work according to specifications. But to ensure this, front-end electronics (electrode cable and input amplifier) have been requested for eval, as well as complementary info of electrode brands used. When skin or scalp electrode is not properly attached this is clearly indicated by the device by giving an alarm. Instructions to check skin and scalp electrodes are already included in the user manuals and it is also part of troubleshooting of signal quality problems in training material. No further field actions are justified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2010-00001 |
| MDR Report Key | 1708026 |
| Report Source | 00,01,08 |
| Date Received | 2010-05-27 |
| Date of Report | 2010-05-25 |
| Date of Event | 2010-04-27 |
| Date Mfgr Received | 2010-04-30 |
| Date Added to Maude | 2011-11-01 |
| 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, 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 | 2010-05-27 |
| Model Number | STAN S31 |
| Catalog Number | ART. NO SYS101003 |
| Lot Number | NA |
| ID Number | SW R3B |
| 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 | 2010-05-27 |