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

Model Number	AVALON FM30 FETAL MONITOR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an avalon fm30 fetal monitor indicating that the monitor showed a drop in the baby's heartrate on several recordings during fetal monitoring.The rate dropped from 150 to 62 bpm and from 120 to 90 bpm for no apparent reason.This occurred several times.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Follow up was conducted to determine if there were multiple patients or products affected; however, this was unknown.Analysis was performed by a remote service engineer (rse) which included communication with the customer and remote troubleshooting.The customer provided images of the issue they were experiencing.Based on the images provided and in accordance with the service guide the rse determined that the issue suggests a switching between the fetal heartrate and maternal heartrate.This phenomenon is typically related to sub-optimal sensor positioning, which may lead to alternating detection between the two heart rates.The rse worked with the customer to create an action plan for testing the sensor and provided a detailed procedure from the service guide.The customer testing confirmed the sensor was in proper working condition.Cross-tests were also performed using the sensor with other monitors in order to verify the phenomenon could not be reproduced and the issue did not recur.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was sub-optimal sensor positioning.The issue was resolved by providing detailed procedure from the service guide and information regarding optimal sensor placement.A review of the service history for this device shows the problem has not been reported again for this device.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: AVALON FETAL MONITOR FM30
• 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: 24133019
• Report Number: 9610816-2026-100120
• Device Sequence Number: 21418453
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/06/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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
• Patient Sex: Unknown