MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FETAL MONITOR FM50; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON FM50 FETAL MONITOR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer biomed did some troubleshooting.Customer stated that one reading would be 120/80 and the next measurement is, 80/78, the next is 140/60.Customer advised that they are not able to duplicate the issue with their simulators.It was confirmed they were using reusable cuffs from medline.Customer told rse that they are no longer getting the errors.The philips clinical specialist advised the customer and staff to make sure the nibp hose is fully seated in the nibp connector.The customer stated to wait a week to determine if issues reoccur and if so they will confirm.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was not replicated and unknown.The customer was provided with some information and the device is working per specification with no errors.
Event or Problem Description
Philips received a complaint on an avalon fm50 fetal monitor indicating that the non invasive blood pressure pump (nibp) was not providing accurate measurements and the fm50 intermittently displays incorrect non invasive blood pressure pump (nibp) readings.The device was in clinical use at time of event, no adverse event was reported.

• Brand Name: AVALON FETAL MONITOR FM50
• 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: 24700902
• Report Number: 9610816-2026-100603
• Device Sequence Number: 16069147
• Product Code: HGM
• UDI-Device Identifier: 00884838000438
• UDI-Public: (01)00884838000438
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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 FM50 FETAL MONITOR
• Device Catalogue Number: 865071
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2025
• 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