MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM20; AVALON FM20 FETAL MONITOR

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	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).Diagnostic/functional testing was performed at the philips authorized repair facility.Results of the evaluation confirmed the customer's alleged malfunction.The philips field service engineer (fse) replaced the speaker assembly to resolve the issue.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be the speaker assembly.The reported problem was confirmed.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.
Event or Problem Description
The customer reported the speaker was faulty.It was confirmed the device neither produced sound nor did it show an inoperative speaker message at the time of the report.The device was not in use on a patient at the time of event, there was no adverse event reported.

• Brand Name: AVALON FETAL MONITOR FM20
• Common Device Name: AVALON FM20 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: 23408513
• Report Number: 9610816-2025-001008
• Device Sequence Number: 15651304
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: (01)00884838000407
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: M2702A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2017
• 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