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

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	05/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an avalon toco+ mp transducer indicating that the toco probe is not functioning.Notes indicate an impact of wrong values produced.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel which included remote troubleshooting with the customer biomed.The results of the analysis confirmed the probe was not functioning.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 a faulty toco probe.A replacement toco probe was sent to the customer to resolve the issue.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: AVALON TOCO+ MP 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: 25546415
• Report Number: 9610816-2026-101178
• Device Sequence Number: 20230206
• Product Code: HGM
• UDI-Device Identifier: 00884838093188
• UDI-Public: (01)00884838093188
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/18/2026

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: 867245
• 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: 05/23/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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