MAUDE Adverse Event Report: PHILIPS ULTRASOUND LLC TRANSDUCER X7-2T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	989605414122
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient who was post-op from bioprosthetic mitral valve and tricuspid valve replacements was decompensating for unknown reasons.We wanted to perform a tee (transesophageal echocardiogram) to assess whether the patient had cardiogenic shock in addition to septic shock.The tee probe in the cvicu (cardiovascular intensive care unit) was scratched and images obtained with the probe were nearly uninterpretable.After a few minutes the probe stopped working completely.We were unable to assess this patient's right heart function.Unfortunately, this significantly delayed the patient going on ecmo (extracorporeal membrane oxygenation) as we needed the imaging to determine which cannula to use.Eventually, we were able to use a pediatric tee probe (the only one available) which produced suboptimal images.

• Brand Name: TRANSDUCER X7-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND LLC; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 20469847
• Report Number: 20469847
• Device Sequence Number: 7613010
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/25/2024
• Report Date (Section F): 09/25/2024

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: 989605414122
• Device Lot Number: F0B6JW
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/25/2024