MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM30

Model Number	AVALON FM30 FETAL MONITOR
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the avalon fm30 fetal monitor displays a speaker malfunction inop error message during the start up of the device and does not emit audible sound.The device was not in use on a patient at the time of the event, there was no patient involvement.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and determined that, apart from a speaker assembly, a main board might need to required as well for the replacement.The customer ordered a replacement speaker and main board to resolve the issue.The customer has assumed the repair responsibility.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).

• Brand Name: AVALON FETAL MONITOR FM30
• Common Device Name: AVALON FETAL MONITOR FM30
• 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: 22883436
• Report Number: 9610816-2025-000775
• Device Sequence Number: 15854232
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 08/25/2025

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 FM30 FETAL MONITOR
• Device Catalogue Number: M2703A
• 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: 07/28/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2017
• 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