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

Model Number	989605414122
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Tee probe was inserted without difficulty.As physician was moving the probe, there was no picture.Changed ultrasound machine and used same probe, and the same issue remained.Probe was removed and ultrasound machine changed out for a second time.Equipment issues caused a delay in care, and the patient received more sedation than he would have needed had the equipment been working.

• Brand Name: TRANSDUCER X7-2T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 8974675
• Report Number: 8974675
• Device Sequence Number: 310714
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 08/20/2019
• Report Date (Section F): 08/20/2019

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
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/20/2019