MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM30 FETAL MONITOR

Model Number	M2703A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
E1: reporting institution phone #: (b)(6).E1: reporter phone #: (b)(6).Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported the user had difficulty differentiating between the maternal heart rate (mhr) and fetal heart rate (fhr) and the baby was stillborn.The 37 week mother presented to the labor ward in severe abdominal pain with a base mhr of 160 bpm.A doppler was performed to determine fetal life prior to connecting the mother to fetal monitor.The staff had difficulty determining which rate was the mhr and fhr, which coincidence alarms being generated by the monitor.The baby was stillborn; however, the fetal movement profile (fmp) was still present.Overall, the staff was confused as to functionality of the monitor and requested assistance for education and explanation of the behavior.Additional information received indicated the cause of death was not known as no autopsy was performed.The fhr alarms were sounding from the beginning of the case onward but the mother was not connected to spo2 or hr monitoring during the birth.The baby was born via c-section and the midwives were unsure whether confusion over the alarms contributed to the outcome.It was also indicated there was no device fault.Further information received indicated the fhr and mhr were too close, with the mhr baseline being 160bpm.The coincidence came from toco as both mhr and fhr can be monitored via this device.The baby was delivered via c-section.The clinical application specialist indicated there was no sign of malfunction.No additional information clarifying the event was received.Based on this information, it remains unclear whether the device caused or contributed to the reported death.
Additional Manufacturer Narrative
Additional information was received which indicated on admission at 0245, doppler was used along with a toco transducer, indicating the mhr was 142 bpm and fhr was 130bpm.An ultrasound was not performed but mhr was measured using a spot check monitor, confirming the heart rate of 142bpm.At 0500, the fhr was 135bpm and mhr was 138bpm.At 0630, fhr was 145bpm and mhr was 138bpm.When the patient complained of abdominal and should pain, the physician suspected placental abruption, so a c-section was performed.At 0720, prior to the c-section, the fhr could not be detected with doppler.A philips field service engineer (fse) evaluated the device and could not confirm the reported, the event data was reviewed which showed coincidence alarm were going off and acknowledged.There is no machine fault as it was working as intended, the device is back in use in the in the labor and delivery suite.A philips clinical scientist reviewed the information provided and concluded that the ctg-recording ran for approximately 3 hours and 20 minutes.During approximately 2 hours and 20 minutes, coincidence alarming¿s were active and acknowledged by the staff.This means, the fhr1 us transducer and toco mp transducer were continuously registering and displaying the signal of the maternal pulse.According to the information provided by the hospital, a countercheck of the maternal pulse by the spo2 finger sensor or the application of mecg has not been performed.This was confirmed by the recordings of the fetal monitor.During the period of ccv alarming¿s and signal loss alarming¿s, an obstetric ultrasonography of the fetal condition has not been performed according to the information provided from the hospital.The device was confirmed to be operating per specifications and no failure was identified.Based on this information, the device did not malfunction and thus, does not appear to have caused or contributed to the reported death.The cause of death remains unknown.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The instructions for use (ifu) warn that a misidentification of the mhr as the fhr can occur.The fhr detection by the monitor may not always indicate that the fetus is alive.The ifu state the importance to confirm fetal life before monitoring, and to continue to confirm that the fetus is the signal source for the recorded heart rate.To assist the user and recognizing possible misidentification of the mhr instead of the fhr, the fetal monitor generates a coincidence inop with a printed question mark on the trace.Further information can be read in the chapter about ¿confirm fetal life before using the monitor¿ and ¿cross-channel verification (ccv)¿.If a coincidence of heart rates is detected, philips recommends following the applicable section of the instructions for use.1.Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or pinard stethoscope.2.Manually determine the maternal pulse and compare with the fetal heart rate sound signals.3.Reposition the transducer or ensure that the fetal scalp electrode is placed correctly, until you receive a clear signal and the monitor is no longer issuing the ¿coincidence inop¿.4.In case of difficulties deriving a stable maternal pulse reading using the toco mp or cl toco mp transducer, use the spo2 finger sensor instead.In case of similar problems with the pulse measurement from spo2 finger sensor, use mecg instead.Reasons to switch the method for deriving a maternal pulse or heart rate include motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via toco mp).5.If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography.

• Brand Name: AVALON FM30 FETAL MONITOR
• Common Device Name: AVALON FM30 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 21596907
• Report Number: 9610816-2025-000208
• Device Sequence Number: 9034651
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M2703A
• Device Catalogue Number: M2703A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown