MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PHILIPS AVALON US TRANSDUCER; TRANSDUCER, ULTRASONIC, OBSTETRIC

Model Number	AVALON US TRANSDUCER
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
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, and a nemo (non engineering material only) service was agreed upon.The customer ordered a replacement transducer to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the avalon us transducer indicating the transducer is not working as normal.Intermittently will not produce sound.The device was in use on patient at time of event, there was no adverse event reported.

• Brand Name: PHILIPS AVALON US 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 ; 70314632031
• MDR Report Key: 24557613
• Report Number: 9610816-2026-100474
• Device Sequence Number: 15668508
• Product Code: HGL
• UDI-Device Identifier: 00884838002722
• UDI-Public: (01)00884838002722
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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 US TRANSDUCER
• Device Catalogue Number: M2736A
• 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: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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