MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM20; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON FM20 FETAL MONITOR
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included visual inspection and functional testing of the device.The results of the analysis indicate the volume had been turned off by the user.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was the volume setting was turned off.The issue was resolved by adjusting the volume setting.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.
Event or Problem Description
Philips received a complaint on an avalon fm20 fetal monitor indicating there was an alarm and no audible sound coming from the speaker.The device was not in use on patient at time of event, there was no adverse event reported.

• Brand Name: AVALON FETAL MONITOR FM20
• 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: 25014469
• Report Number: 9610816-2026-100803
• Device Sequence Number: 10302935
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: (01)00884838000407
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: Other
• Device Model Number: AVALON FM20 FETAL MONITOR
• Device Catalogue Number: 862198
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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