STAN S31 FETAL HEART MONITOR
Report
- Report Number
- 3004729605-2010-00001
- Event Type
- Malfunction
- Date Received
- May 27, 2010
- Date of Event
- April 27, 2010
- Report Date
- May 25, 2010
- Manufacturer
- NEOVENTA MEDICAL AB
- Product Code
- HEO
- PMA / PMN Number
- P020001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAN S31 FETAL HEART MONITOR | HEO: OBSTETRIC DATA ANALYZER | HEO | NEOVENTA MEDICAL AB | STAN S31 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |