MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM30; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON FM30 FETAL MONITOR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Respiratory Acidosis (2482); Insufficient Information (4580)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the user confused the maternal and fetal heart rates, which led the physician to interpret the ctg tracing as better than the actual condition of the fetus.From 1240-1255, the monitor trace displayed the fetal heart rate (fhr) but not the maternal heart rate (fhr); however, the physician believes the monitor was actually capturing mhr.It was also noted that the fhr and mhr were at the same base rate, but the pattern of fetal heart sounds differed.Based on this information, the physician concluded the displayed heart rate was actually the mhr and not the fhr.Following delivery of the baby, the baby's umbilical cord ph was 6.90, which reflects acidosis.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Regarding alarms, it was indicated "several alarms were recorded.These occurred during periods of good and continuous maternal heart rate signal acquisition, with simultaneous poor signal acquisition from the fetus.Toward the end of the recording, when the maternal heart rate was displayed as the fetal trace, no separate maternal heart rate trace was present, nor was any tocodynamometer recording available".The device was reviewed by hospital engineering, revealing no abnormalities, and the device was returned to use.The customer requested education on how to prevent this issue in the future.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
It was reported the user confused the maternal and fetal heart rates, which led the physician to interpret the ctg tracing as better than the actual condition of the fetus.From 1240-1255, the monitor trace displayed the fetal heart rate (fhr) but not the maternal heart rate (fhr); however, the physician believes the monitor was actually capturing mhr.It was also noted that the fhr and mhr were at the same base rate, but the pattern of fetal heart sounds differed.Based on this information, the physician concluded the displayed heart rate was actually the mhr and not the fhr.Following delivery of the baby, the baby's umbilical cord ph was 6.90, which reflects acidosis.Additional information indicated the user confused the maternal and fetal heart rates, which led to an interpretation the fetus was in better condition than it was.A fetal scalp electrode was applied, revealing the heart rates were likely misinterpreted.The umbilical artery had a ph of 6.91 at birth with apgars of 2-9-9.Positive pressure ventilation was administered for 3 minutes, after which the infant recovered and was fed a 20ml bottle of formula.The event was assessed as a transient perinatal asphyxia episode, so no permanent harm.The infant was discharged to home with the parents and medical records indicated no further hospital care was required and development has been normal.Regarding alarms, it was indicated "several alarms were recorded.These occurred during periods of good and continuous maternal heart rate signal acquisition, with simultaneous poor signal acquisition from the fetus.Toward the end of the recording, when the maternal heart rate was displayed as the fetal trace, no separate maternal heart rate trace was present, nor was any tocodynamometer recording available".The device was reviewed by hospital engineering, revealing no abnormalities, and the device was returned to use.The customer requested education on how to prevent this issue in the future.

• Brand Name: AVALON FETAL MONITOR FM30
• Common Device Name: SYSTEM, MONITORING, PERINATAL
• 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: 24475093
• Report Number: 9610816-2026-100411
• Device Sequence Number: 16021713
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVALON FM30 FETAL MONITOR
• Device Catalogue Number: 862199
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2019
• 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: Required Intervention
• Patient Sex: Unknown