MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH Avalon CL Ultrasound Transducer; Transducer, Ultrasonic, Obstetric

Model Number	Avalon Cableless US Transducer
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device is not reading correctly.The device was not in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel which included troubleshooting with the customer.The remote support engineer (rse) confirmed the reported issue could be replicated as the device displays a constant battery malfunction error even with a new battery inside.The results of the analysis were that the ultrasound transducer was found defective and needed replacement.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 a defective transducer.The issue was resolved by providing the replacement part number to the customer.A review of the service history for this device shows the problem has not been reported again for this device.

• Brand Name: Avalon CL Ultrasound Transducer
• Common Device Name: Transducer, Ultrasonic, Obstetric
• 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 ; +49(703)14632031
• MDR Report Key: 50755680
• Report Number: 9610816-2026-101885
• Device Sequence Number: 13178777
• Product Code: HGL
• UDI-Device Identifier: 00884838034242
• UDI-Public: (01)00884838034242
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/14/2026

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: Other
• Device Model Number: Avalon Cableless US Transducer
• Device Catalogue Number: 866076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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