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

Model Number	M2734B
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
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: (b)(6).
Event or Problem Description
It was reported a patient in the delivery room developed an irritation burn at the site of the transducer.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Event or Problem Description
As the reported event regarding the patient burn was not a life-threatening, there was no intervention aside from an ointment performed, and no indication of permanent damage.This report is no longer considered to be a serious injury.The burn is considered to be a minor second-degree burn.
Additional Manufacturer Narrative
The philips key market representative (km) interviewed the customer, and it was confirmed the burn was located on the abdomen above navel with the shape of the transducer.It is described as a second-degree burn, where the skin was irritated for several hours and treated with flaminal hydro ointment.The patient did not have any known pre-existing skin sensitivities/allergies.After further investigation, this event is not a reportable with philips based on the following skin conditions that were not considered to be serious injuries: blisters, minor burns, bumps, cuts.Since the previous mentioned will not result in permanent impairment of a body function or permanent damage to a body structure; or necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Furthermore, it is expected clinical practice to regularly verify the skin at the application site.It was not recommended to have the transducers fixed to one location over a prolonged period of time.This could cause pressure sores and could lead to a break in the skin integrity.It was advised to choose the proper belt size for your patient and assess the skin under the transducer at a regular time interval.In the case of allergic reactions or skin irritation due to transducer housing material, cables or fixation belts, it should be noted that all material used for transducers, and belts which come directly in contact with the skin have been tested and approved.The product labeling clearly states the importance of inspecting the skin/application site regularly and to reposition the transducers if required.In the instance of a skin reaction due to cleaning/disinfection agents, the product labeling also clearly explains which products are approved by philips and the importance of removing the disinfection agent before applying the transducers on the patient.This is deemed not reportable event.

• Brand Name: AVALON TOCO MP TRANSDUCER
• Common Device Name: AVALON 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: 20896181
• Report Number: 9610816-2024-000955
• Device Sequence Number: 21093295
• Product Code: MHX
• UDI-Device Identifier: 00884838021471
• UDI-Public: (01)00884838021471
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K110622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: M2734B
• Device Catalogue Number: M2734B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/27/2025
• Date Device Manufactured: 07/31/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown