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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer head nurse.According to the nurse, after having done the same tests with the same ultra-sound probe with other patients, the problem has not been found anymore.In agreement with the customer, the call was closed.Based on the information available, we were unable to replicate the reported problem.The reported problem was not confirmed, but could not be ruled out at the time of the initial event.The device was found to be operating per specifications and no failure was identified, at the time the nurse tested the probe.The cause of the issue was unable to be confirmed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.E1: reporter and reporting institution phone #: (b)(6).
Event or Problem Description
Philips received a complaint on an avalon fm30 fetal monitor indicating that the monitor reports a fetal heart rate that does not correspond to the auscultated heart rate and consequently marks alarm continuously.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• 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: 23403601
• Report Number: 9610816-2025-001004
• Device Sequence Number: 13023239
• Product Code: HGM
• UDI-Device Identifier: 00884838000414
• UDI-Public: (01)00884838000414
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Nurse
• 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: Health Professional
• Device Model Number: AVALON FM30 FETAL MONITOR
• Device Catalogue Number: M2703A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2023
• 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: Female