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

Model Number	AVALON TOCO MP TRANSDUCER
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by philips field service engineer (fse), who went onsite.The fse performed a visual inspection and found the membrane torn.The fse performed a function test, and there was no connection to the ctg.The fse determined that the housing was defective, but housing is not available as a spare part.No repair is possible, only replacement.Based on the results of the analysis, the fse determined that the defect is attributable to misuse.The issue was resolved by providing a replacement transducer.Section e: reporting institution phone #: (b)(6).Section e: reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on the avalon toco mp transducer indicating that the toco measurement was unreliable, and there was material damage present on the underside.The device was in use on a patient at the time of the event.There was no adverse event reported.

• Brand Name: AVALON 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: 25376909
• Report Number: 9610816-2026-101085
• Device Sequence Number: 10552004
• Product Code: HFM
• UDI-Device Identifier: 00884838021471
• UDI-Public: (01)00884838021471
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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 TOCO MP TRANSDUCER
• Device Catalogue Number: M2734B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2019
• 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