MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM50

Model Number	AVALON FM50 FETAL MONITOR
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported the device is double counting heart rate and not identifying patients correctly.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
The philips technical consultant (tc) went to the customer site and performed scans of the network connectivity.Philips national service support (nss) reviewed the data obtained by the tc.There was an issue with the network signal in the affected area, which was determined to be related to a non-philips product in the customer environment.The installation was completed without issues originally; the non-philips product in the customer environment may have changed causing the technical issue.Fm monitor channels were adjusted by the tc to follow guidelines in the service manual using data from the rf environment collected from the fm scans.This resolved the technical issue.Double counting was part of the main complaint and it was noted by the nss that philips does outline mitigations for this in the instructions for use (ifu) for the product.The device was operational after adjusting the fm monitor channels.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: AVALON FETAL MONITOR FM50
• Common Device Name: AVALON FETAL MONITOR FM50
• 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: 22568657
• Report Number: 9610816-2025-000646
• Device Sequence Number: 13070827
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: (01)00884838000438
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: Health Professional
• Device Model Number: AVALON FM50 FETAL MONITOR
• Device Catalogue Number: 865071
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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