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

Model Number	AVALON FM20 FETAL MONITOR
Medical Device Problem Codes	No Audible Alarm (1019); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1; reporter institution phone number (b)(6).E1: reporter phone number (b)(6).The distributor performed the troubleshooting and determined that the speaker cable is faulty and must be replaced.A quote has been sent to purchase the part.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
The customer reported that there was error message "speaker malfunction" occurs.The device is in clinical use at time of event, no adverse event was reported.
Additional Manufacturer Narrative
The distributor spoked with the biomed and confirmed there was no sound.Some troubleshooting work was completed and determined that the speaker cable is faulty and must be replaced.The speaker needed to be replaced.A quote was sent to customer.Based on the information available cause of the reported problem was a faulty speaker cable.The reported problem was confirmed.Multiple attempts were made to obtain the device context of use, evaluation, repair, and operational status with no response from the customer and the quote expired.No further information was provided.A supplemental report will be submitted if new information is obtained.

• Brand Name: AVALON FM20 FETAL MONITOR
• 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: 23575985
• Report Number: 9610816-2025-001078
• Device Sequence Number: 9398545
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: M2702A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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