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

Model Number	AVALON CABLELESS TOCO+ MP TRANSDUCER
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported, the transducers are crumbling when cleaned with oxivir excel wipes.This reported issue is occurring at several customer hospital sites.No other clinical information or medical intervention was.
Event or Problem Description
There was no adverse event reported.
Additional Manufacturer Narrative
After further investigation this complaint is deemed not a reportable event with philips.Physical damage or a defect of the device would be obvious to the user when monitoring under close personal surveillance, as described in the product labeling shipped with the device.This would prompt the user to use alternative methods of monitoring or to troubleshoot the device.Product labeling instructs users to perform a visual inspection before each use, and in accordance with the hospital's policy including inspection of all accessories (transducers, sensors and cables).Users are instructed to not use a damaged accessory.Examine all system cables, the power plug and cord for damage.Make sure that the prongs of the plug do not move in the casing.If damaged, replace it with an appropriate power cord.Inspect the cables, leads and their strain reliefs for general condition.Make sure there are no breaks in the insulation.Make sure that the connectors are properly engaged at each end to prevent rotation or other strain.Therefore deemed not reportable.

• Brand Name: AVALON CABLELESS 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: 23349560
• Report Number: 9610816-2025-000981
• Device Sequence Number: 7818937
• Product Code: HFM
• UDI-Device Identifier: 00884838034235
• UDI-Public: (01)00884838034235
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVALON CABLELESS TOCO+ MP TRANSDUCER
• Device Catalogue Number: 866075
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 08/21/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown