MAUDE Adverse Event Report: PHILIPS ULTRASOUND X7-2T; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	TRANSDUCER X7-2
Medical Device Problem Codes	Overheating of Device (1437); Failure to Calibrate (2440)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Tachycardia (2095)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an incident where the x7-2t transducer was not recognized and then displayed a warning message that the transducer was overheating on the ultrasound system.The transducer was removed from the patient.It was alleged that the patient was hypertensive and tachycardic.Additional information is being gathered regarding event details and root cause of the issue which will be included in a follow up report.
Additional Manufacturer Narrative
An engineering investigation was initiated, however there was insufficient information to conduct the investigation.Essential information such as (pictures, descriptions of event, usage situation, cleaning method) were not available.Furthermore, the suspect transducer was not returned in its the original failure condition for reproducing the issue.The customer received a replacement transducer to resolve their immediate issue.
Additional Manufacturer Narrative
An addendum report is being submitted to provide the date received by manufacturer with the philips¿ become aware date.The information is in the g3 field.

• Brand Name: X7-2T
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 18085987
• Report Number: 3019216-2023-00159
• Device Sequence Number: 17820811
• Product Code: IYN
• UDI-Device Identifier: 00884838075177
• UDI-Public: 00884838075177
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030455
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

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: TRANSDUCER X7-2
• Device Catalogue Number: 989605461941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/22/2024; 10/18/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 09/04/2024; 09/05/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown