MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER

Model Number	867246
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips rse contacted the customer and confirmed the reported issue of inaccurate fhr (fetal heart rate) being produced when monitoring multiple fetuses.The issue occurred when monitoring with a wired us transducer with firmware (fw) l.01.04.Philips investigated these complaints, documented under (b)(4), and determined that this issue is caused by changes implemented under engineering change (b)(4), released 25may2023.These changes updated the ultrasound transducer with a new cpu board and firmware in response to a shortage of multiple components.Due to a chip shortage situation, a hw/sw design change was required, which introduced a performance issue to the fetal heart rate (fhr) measurement of wired ultrasound (us) transducers.The need for subtle adjustments of the transmit/receive time windows in us measurements unexpectedly introduced interference with adjacent transducers (twin/triplet use cases) by generating measurable artificial rhythmic signals that can be interpreted as actual physiological signals (fetal heart beats).This investigation determined that the new firmware (453564254621-s-fw-01, rev l.01.04) which is designed for all avalon transducers, shows an unexpected issue for the ultrasound transducer (867246).When monitoring multiples (twins or triplets), the wired avalon ultrasound transducers (product no.867246) have a tendency to produce an artificial fetal heart rate (fhr) instead of fhr gaps, mostly at approximately 180 bpm, in situations where the physiological signal (echo from pulsating fetal heart) is absent or very weak.Based on the information available and the testing conducted, the cause of the reported problem was design defect in the transducer's firmware.The reported problem was confirmed.The fco has been implemented; the issue was resolved after updating the transducer fw to rev.L.01.05.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Box e: reporting institution phone #: (b)(6).
Event or Problem Description
Philips received a complaint on the avalon us transducer indicating that there were inaccurate fetal heart rate (fhr) measurements when monitoring multiple fetuses.The device was in clinical use at the time of event.There was no adverse event or patient harm reported.

• Brand Name: AVALON US TRANSDUCER
• Common Device Name: AVALON US TRANSDUCER
• 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: 21395613
• Report Number: 9610816-2025-000107
• Device Sequence Number: 20950090
• Product Code: HGL
• UDI-Device Identifier: 00884838093195
• UDI-Public: (01)00884838093195
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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: 867246
• Device Catalogue Number: 867246
• 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: 01/22/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2239-2024
• Patient Sequence Number: 1
• Patient Sex: Female