MAUDE Adverse Event Report: PHILLIPS MEDICAL SYSTEMS IE33 X7-2T TRANSDUCER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number X7-2T

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/02/2015

Event Type  malfunction  

Event Description

Patient prepared for and consented to have transesophageal echocardiography (tee).Tee probe was inserted by fellow doctor with assistance from a second doctor.When the probe was inserted, no images were showing on the screen.The tee probe was found to be disconnected by registered diagnostic medical sonographer.Probe was not locked into machine due to possible lock malfunction.Tee probe was immediately extubated and switched out for extra probe in unit.Patient was reintubated and the tee successfully performed.

• Brand Name: IE33 X7-2T TRANSDUCER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILLIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 4544695
• MDR Text Key: 5515949
• Report Number: 4544695
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/18/2015

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
• Device Operator: Invalid Data
• Device Model Number: X7-2T
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR