MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON PATIENT MODULE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	AVALON PATIENT MODULE
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A replacement device was sent to the customer.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.
Event or Problem Description
Philips received a complaint on an avalon patient module indicating that the device was not reading correctly.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
No testing was done; however, remote service personnel performed remote communication and troubleshooting with the customer biomed.The customer indicated there was a brief delay in monitoring the patient's heartrate; however, the nursing staff swapped the module for another to resolve the issue.Based on the results of the information available, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a faulty ecg/iup module.The issue was resolved by replacing the module.Based on the information available, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
Philips received a complaint on an avalon patient module indicating that the device was not reading correctly.It was noted that they were not able to successfully perform direct ecg fetal heartrate measurement using fetal scalp electrodes.The device was in use on a patient at time of event, there was no adverse event reported.

• Brand Name: AVALON PATIENT MODULE
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• 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: 24256711
• Report Number: 9610816-2026-100187
• Device Sequence Number: 8355915
• Product Code: DSA
• UDI-Device Identifier: 00884838012141
• UDI-Public: (01)00884838012141
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 03/06/2026

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 PATIENT MODULE
• Device Catalogue Number: 989803144241
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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