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

Model Number 989605414122

Device Problem No Device Output (1435)

Patient Problem No Code Available (3191)

Event Date 07/18/2019

Event Type  malfunction  

Event 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
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 8974675
• MDR Text Key: 156912534
• Report Number: 8974675
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605414122
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10950 DA