MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CL TOCO+ MP TRANSDUCER; AVALON CABLELESS TOCO+ MP TRANSDUCER

Model Number	AVALON CABLELESS TOCO+ MP TRANSDUCER
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported blisters formed under the transducer during use.The blistering was raised, clear, fluid filled and occurred under the smooth part of the transducer.The transducer was in place approximately 3-4 hours.The physician was notified but the blistering was not classified in a burn category.There was no treatment provided, and the burn was expected to heal completely.The transducer was moved to another area on the abdomen, but it was not noted by the user if the transducer was hot to the touch.The specific transducer could not be located for analysis.
Additional Manufacturer Narrative
Patient involvement was reported.The patient experienced skin blistering during use.The blistering was not classified in a burn category and were expected to heal completely.Information provided indicated the blistering was raised, clear, fluid filled and occurred under the smooth part of the transducer and was supported by the provided picture.The transducer was in place approximately 3-4 hours.The fse confirmed that the unit manager did not take any detailed information of the events including device serial numbers involved nor were the devices alleged in the incident sequestered for evaluation.The investigation did find that the customer is using unapproved disinfectant wipes.Additionally, the customer is not following the instructions for use (ifu) which instruct that the device be wiped off with a cloth dampened with water, after allowing the appropriate time for agent to work.It was confirmed with the unit manager that there have not been any new cases since the original confirmed occurrences.While a definitive cause has not been determined, the unit manager also agreed that staff will start wiping down the devices with a wet cloth per the ifu instructions and to sequester any other devices that cause injury in the future and to call us back if it happens.Since the devices in question were not sequestered and were put back into circulation, a proper evaluation has not been able to be completed, there is insufficient information to be able to determine cause.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 CL TOCO+ MP TRANSDUCER
• Common Device Name: AVALON CABLELESS TOCO+ MP 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: 23299875
• Report Number: 9610816-2025-000952
• Device Sequence Number: 4798144
• Product Code: HFM
• UDI-Device Identifier: 00884838034235
• UDI-Public: (01)00884838034235
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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 CABLELESS TOCO+ MP TRANSDUCER
• Device Catalogue Number: 866075
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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: Female