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	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when monitoring twins, the fetal heart rate (fhr) measured by the us transducer is inaccurate.The heart rate is higher than the value measured by a stethoscope or an echography.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.The investigation has been escalated.
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.
Additional Manufacturer Narrative
The investigation determined that between 9:40 and 9:50, the customer identified that hr1 (heart rate 1) was averaging 170 beats per minutes (bpm) and after 10 a.M.The customer observed an average of 160 bpm.Normal bpm values for a newborn are between 100 and 160 bpm, so the customer identified a tachycardia on the hr1.On hr2, since there was a +20 bpm shift and the bpm was found to be between 115 and 120 bpm.The hr1 was verified with an echography and this measurement read closer to the hr2 value.The heart rate was further checked by stethoscope, ultrasound and a second cardiotocograph between 10 and 11 a.M.On the same day.The case was escalated and review of the traces by the product specialist identified an artifact in the signal.A philips field service engineer (fse) was dispatched.The fse verified that the customer was running the current firmware version l.01.05 covered in fco86202016a.The ultrasound transducer underwent functional testing and was found to perform as expected.The readings measured as expected.There was no visible physical damage to the device.Finally, the fse tested the twin functionality and successfully measured two signals.All testing performed as expected.The reported problem was not confirmed.Information was provided to the customer and the customer will create a new case if they find the issue repeats.Related case for serial number: (b)(6) is reported under mfr report number: 9610816-2024-00514.

• 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: 19974705
• Report Number: 9610816-2024-00513
• Device Sequence Number: 8432678
• Product Code: HGM
• UDI-Device Identifier: 00884838093195
• UDI-Public: (01)00884838093195
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/04/2024

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: 07/19/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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