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 Code	Burn(s) (1757)
Date of Event	07/19/2023
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 that a patient received a burn from a toco transducer.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
The device was sent to the philips product support engineer (pse) and research and development (r&d) to be evaluated.As per r&d there were no signs of malfunction or defect in the transducer.The skin burn issue appears due to skin irritation/allergy, because of chemical reaction between rest particles of cleaning agent on the surface of the transducer and skin.To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment's 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.As per r&d there were no signs of malfunction or defect in the transducer.The skin burn issue appears due to skin irritation/allergy.There was a chemical reaction between the rest of the particles of cleaning agent on the surface of the transducer and skin.
Event or Problem Description
It was reported that a patient received a burn from a toco transducer.The patient received a burn from a toco transducer.The device was in use monitoring a patient at the time of the 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: 17559962
• Report Number: 9610816-2023-00409
• Device Sequence Number: 7548523
• Product Code: MHX
• UDI-Device Identifier: 00884838021471
• UDI-Public: 00884838021471
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• 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: Hospitalization
• Patient Sex: Unknown