MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CL TOCO+ MP TRANSDUCER; MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

Model Number	AVALON CABLELESS TOCO+ MP TRANSDUCER
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporting institution phone: (b)(6).E1: reporter phone# (b)(6).A philips remote service engineer (rse) spoke to the customer, a biomedical engineer, who reported that the device was not reading correctly when pressure was applied during testing/quality control and was outside of use at the time of the event.The rse confirmed the issue was replicated; pressure readings were inaccurate and did not respond correctly when pressure was applied.Functional testing indicated a likely fault with the transducer.The customer was quoted for an exchange transducer to resolve the issue.The customer was provided with part information to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the avalon cableless toco+ mp transducer indicating that the device is not reading correctly when pressure is applied.The device was not in use on patient at time of event, there was no adverse event reported.

• Brand Name: AVALON CL TOCO+ MP TRANSDUCER
• Common Device Name: MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)
• 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: 25490956
• Report Number: 9610816-2026-101131
• Device Sequence Number: 16033017
• Product Code: HFM
• UDI-Device Identifier: 00884838034235
• UDI-Public: (01)00884838034235
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/12/2026

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 TOCO+ MP TRANSDUCER
• Device Catalogue Number: 866075
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown