MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM20; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON FM20 FETAL MONITOR
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips was advised that on january 6, during labor, the fetal heart monitor could not detect uterine contractions due to an insensitive contraction probe.Another fetal heart monitor was immediately used to complete monitoring.Additional information was requested to identify the attached probe/transducers, but no additional identification information was provided.Philips was advised that the hospital sought the services of a third-party to repair the uterine contractions probe, and the equipment resumed normal operation.No additional information was provided.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 # (b)(6).Reporter phone # (b)(6).
Event or Problem Description
It was reported the fetal monitor could not detect uterine contractions due to an insensitive transducer probe, so the monitor was exchanged immediately to continue monitoring.The patient was admitted for termination of the pregnancy at 38 weeks two days and uterine contractions could not be measured adequately.The customer indicated this issue could have led to inadequate observation during labor and rapid delivery.In addition, the feedback form indicated this was a serious injury with the injury being an increase in cesarean section rate; however, this patient did not have a cesarean for this event.It was clarified there was no actual harm to the patient.

• Brand Name: AVALON FETAL MONITOR FM20
• 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: 24278504
• Report Number: 9610816-2026-100219
• Device Sequence Number: 8365508
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2020
• 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 Age: 25 YR
• Patient Sex: Female