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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Blister (4537)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported blisters were present on the patient under the ultrasound transducer during use.No other clinical information or medical intervention was reported.
Additional Manufacturer Narrative
The preliminary investigation indicates that the customer is using an unapproved disinfecting agent when cleaning the device.Additionally, the device is not wiped following the cleaning.The product instructions for use indicate the following: warning skin contact: to reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work.Follow the safety instructions of the used cleaning or disinfection agent, especially regarding skin contact.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.
Additional Manufacturer Narrative
A philips field service engineer (fse) was dispatched.The fse confirmed that the unit manager did not sequester devices for evaluation.The device was added back to the device pool.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.Per the avalon fetal monitor fm20/30, fm40/50, avalon cl, release l.3 with software revision l.3x.Xx instructions for use, part number 453564898421 p.258 warning skin contact: to reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work.Follow the safety instructions of the used cleaning or disinfection agent, especially regarding skin contact.A device malfunction was not confirmed.The customer was advised to follow the cleaning protocol provided in the ifu.The customer has agreed to sequester any other devices exhibiting the issue in the future and to notify philips immediately.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 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: 23312353
• Report Number: 9610816-2025-000959
• Device Sequence Number: 4989085
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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
• 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: 10/22/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female