MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON TOCO+ TRANSDUCER; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON TOCO+ TRANSDUCER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the toco+ transducer with serial number (b)(6), which belongs to the fetal monitor with serial number (b)(6), is broken.It was indicated that it does not measure correctly, nor does it calibrate the baseline correctly.The device was in use on a patient at the time of the event.There was no adverse event reported.
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.Section e: reporter and reporting institution phone #: (b)(6).
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer, who indicated that the transducer was faulty.Based on the results of the analysis, it was determined that the product has malfunctioned, and the most likely cause of the reported problem was the transducer.The issue was resolved by sending a replacement transducer to the customer site.Updated product information from the avalon fm30 fetal monitor to the avalon toco+ transducer, as the issue lies with the transducer.

• Brand Name: AVALON TOCO+ TRANSDUCER
• Common Device Name: SYSTEM, MONITORING, PERINATAL
• 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: 24285327
• Report Number: 9610816-2026-100231
• Device Sequence Number: 8289916
• Product Code: HGM
• UDI-Device Identifier: 00884838093225
• UDI-Public: (01)00884838093225
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/12/2026

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 TOCO+ TRANSDUCER
• Device Catalogue Number: 867249
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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