MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON TOCO+ TRANSDUCER

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	07/31/2025
Type of Reportable Event	Malfunction
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.E1: reporting institution phone #: (b)(6).Reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on an avalon toco+ transducer indicating that the breakdown that the toco presents never goes above 120 bpm, you try with another toco and there is a difference in the measurements.It is unknown if this issue was with the fetal heart rate or maternal heart rate.It was unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
Additional information was requested, and a quote for service was provided.However, the quote was rejected by the customer.No further information was provided on this event.Based on the information available, we were unable to replicate the reported problem.The reported problem was not confirmed but could not be ruled out due to a lack of information.We are unable to confirm the final disposition of the device because the customer did not respond to requests for additional information and did not accept the provided service quote.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: AVALON TOCO+ TRANSDUCER
• Common Device Name: AVALON TOCO+ TRANSDUCER
• 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: 22787217
• Report Number: 9610816-2025-000734
• Device Sequence Number: 18201905
• 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): 09/05/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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