MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CL BASESTATION

Model Number	866074
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) spoke with the customer onsite to evaluate the device in question.The fse indicated during an evaluation that the customer had multiple cordless and corded transducers undocked from the system.The fse explained to the customer that both cordless and corded transducers could not be undocked from the system simultaneously.The fse instructed the customer to dock all cordless transducers when using corded transducers.The customer issue was resolved, and additional education was provided to the onsite staff.
Event or Problem Description
Philips received a complaint on the avalon cl base station indicating the system produces an inaccurate intrauterine pressure measurement.The device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.

• Brand Name: AVALON CL BASESTATION
• Common Device Name: AVALON CL BASESTATION
• 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: 21525430
• Report Number: 9610816-2025-000176
• Device Sequence Number: 9584850
• Product Code: HGM
• UDI-Device Identifier: 00884838034228
• UDI-Public: (01)00884838034228
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: 866074
• 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: 02/06/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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