MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 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	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) verified the avalon ultrasound transducer needed to be replaced.The rse verified customers contact and shipping information in the system is correct and placed a parts order.Based on the information available and the testing conducted, the cause of the reported problem was a faulty transducer.The reported problem was confirmed.The customer was provided a replacement device 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 an avalon us transducer indicating that the customer biomedical engineer (biomed) stated the unit is not making any sound.The device was not in clinical use at the time the issue was discovered.No adverse event or harm was reported.

• Brand Name: 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: 23827283
• Report Number: 9610816-2025-001241
• Device Sequence Number: 18381094
• Product Code: HGL
• UDI-Device Identifier: 00884838002722
• UDI-Public: (01)00884838002722
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/17/2025

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: AVALON US TRANSDUCER
• Device Catalogue Number: M2736A
• 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: 11/17/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown