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	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).A philips remote technical consultant (tc) interviewed the customer and suggested the issue may stem from a faulty speaker cable, speaker assembly or main board.It was discovered the main cpu board needed to be replaced to resolve the issue.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
Customer reported that the device is showing an inop speaker malfunction.It was confirmed the device did not produce sound at the time of the report.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by a philips remote technical consultant (tc) which included interviewing the customer.The tc suggested the issue may stem from a faulty speaker cable, speaker assembly or main board.It was discovered the main cpu board needed to be replaced to resolve the issue.The tc provided the customer a quote for onsite repair and informed them the job will not be covered by warranty-contract-rsm-quote.The customer did not reply.Eventually, the onsite quote expired and the case closed.Based on the information available in the case and provided by the philips personnel, the cause of the reported problem was confirmed to be the cpu board.The alleged malfunction was confirmed.If additional information is received, the complaint file will be reopened for further investigation.

• 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: 24854190
• Report Number: 9610816-2026-100684
• Device Sequence Number: 15762737
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: (01)00884838000407
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 05/22/2026

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 FM20 FETAL MONITOR
• Device Catalogue Number: 862198
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2018
• 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