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

Model Number	867246
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the system is having problems recording fetal heart rate intermittently.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.The manufacturing date for the reported device is prior to 24sept2016 so no udi required.Reporting institution phone # (b)(6).
Additional Manufacturer Narrative
Based on the information available and the testing conducted, the cause of the reported problem was a design defect in the transducer's firmware (fw).Philips investigation determined this issue is caused by changes implemented under an engineering change released (b)(6),2023.These changes updated the ultrasound t=transducer with a new central processing unit (cpu) board and firmware in response to a shortage of multiple components.Due to a chip shortage situation, a hardware (hw)/software (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.A field change order (fco) was implemented on ((b)(6)2024) to update the transducer firmware.The fco has been implemented, the issue was resolved after updating the transducer firmware.
Event or Problem Description
Philips received a complaint on the avalon us transduce indicating that the system continues to show too high values for fetal heart rates 180bpm".The device was in clinical use at the time of the event and no adverse event occurred.

• 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: 19906612
• Report Number: 9610816-2024-00488
• Device Sequence Number: 12930128
• Product Code: HGM
• UDI-Device Identifier: 00884838093195
• UDI-Public: (01)00884838093195
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 07/09/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2011
• 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: Unknown