MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CL BASE STATION; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number	AVALON CL BASESTATION
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by philips remote clinical specialist reviewed the tracing where there was fhr and mhr dropout/incorrect rate while patient was walking.The tracing was from a 3rd party central station and not the paper recording as the customer claimed that they do not have the recorder paper to provide.The tracking appeared to be artifact and possible maternal insertion where fhr is picking up maternal rate.Based on the results of the analysis, it was determined that the product functioned as intended and there was no malfunction.The remote clinical specialist provided instructions for use and recommended review of chapter 12 monitoring with ultrasound.A review of the service history for this device shows there have been no additional issues reported related to this device.
Event or Problem Description
Philips received a complaint on an avalon cl basestation that when the patient walked out the room it was giving a false negative that her and the baby heart rate was dropping.The device was in clinical use at time of event, no patient or user harm was reported.

• Brand Name: AVALON CL BASE STATION
• Common Device Name: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• 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: 25064059
• Report Number: 9610816-2026-100834
• Device Sequence Number: 13253079
• Product Code: DRG
• UDI-Device Identifier: 00884838034228
• UDI-Public: (01)00884838034228
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/03/2026

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 CL BASESTATION
• Device Catalogue Number: 866074
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2024
• 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