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

Model Number	AVALON CABLELESS ECG/IUP TRANSDUCER
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts were made to obtain additional information from the customer; however, no response was received.Consequently, no further details were available for assessment.No cause of death was reported, and there were no allegations indicating device malfunction, misuse, or contribution to the event.Based on the information available, the investigation was unable to identify any device-related involvement in the reported event.The product malfunction was unable to be confirmed because the customer did not respond to requests for additional information.A review of the service history for this device confirms the problem has not been reported again for this device.
Event or Problem Description
Philips received a complaint on an avalon cableless ecg/iup transducer indicating that there was no sound.It is unknown if the device was in use at time of event, and there was no adverse event reported.

• Brand Name: AVALON CL ECG/IUP TRANSDUCER
• 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: 24341611
• Report Number: 9610816-2026-100301
• Device Sequence Number: 18522556
• Product Code: DSA
• UDI-Device Identifier: 00884838034259
• UDI-Public: (01)00884838034259
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/16/2026

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 CABLELESS ECG/IUP TRANSDUCER
• Device Catalogue Number: 866077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/15/2026
• Date Device Manufactured: 07/30/2025
• 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