MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM30 FETAL MONITOR; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON FM30 FETAL MONITOR
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an avalon fm30 fetal monitor indicating that there was an alarm malfunction.The device was not in clinical use at the time the issue was discovered.No adverse event or harm was reported.
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site, and confirmed the alarm was malfunctioning.The fse found the fetal monitor settings to be abnormal; therefore, the fse reset the settings.Information was not provided on how the settings became abnormal.The device passed a functional, visual and network check, and also passed an ecg check.The device was placed back into service.Based on the information available and the testing conducted, the cause of the reported problem was the abnormal device settings.The reported problem was confirmed.The device was operational after the settings were reset.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 FM30 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: 23569141
• Report Number: 9610816-2025-001069
• Device Sequence Number: 10129394
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• 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): 11/17/2025

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
• Device Model Number: AVALON FM30 FETAL MONITOR
• Device Catalogue Number: M2703A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2017
• 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