MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM20

Model Number	AVALON FM20 FETAL MONITOR
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips authorized service personnel (asp) reached out to the customer, who determined that the fetal heart rate probe was faulty.After the fetal heart rate probe was replaced in the hospital's equipment department, the equipment resumed normal use.Based on the information available and the testing conducted, the cause of the reported problem was the fetal heart rate probe.The reported problem was confirmed.The device was operational after replacing the heart rate probe.Section e reporting institution phone #: (b)(6).Section e reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on the avalon fm20 fetal monitor indicating that a pregnant woman came to the hospital for treatment on (b)(6), 2025, at 20:27.According to the doctor's advice, a fetal heart rate monitor was performed.During the monitoring process, the fetal monitoring machine showed that the fetal heart rate fluctuated between 90 and 210 beats per minute, indicating poor fetal monitoring signals.The doctor was immediately informed.The doppler auscultation of the fetal heart rate was between 130 and 150 beats per minute, which was within the normal range.The device was in use on a patient at the time of the event.There was no adverse event reported.

• Brand Name: AVALON FETAL MONITOR FM20
• Common Device Name: AVALON FETAL MONITOR FM20
• 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: 22788836
• Report Number: 9610816-2025-000735
• Device Sequence Number: 15487438
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: (01)00884838000407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/12/2025

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 FM20 FETAL MONITOR
• Device Catalogue Number: 862198
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• 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