MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number M00499120

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2017

Event Type  malfunction  

Event Description

We hooked up ultra ice like normal and an error message appeared on the screen.We tried to unplug and checked connection but nothing worked, so a new one was used and worked fine.

• Brand Name: ULTRA ICE PLUS
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 47215 lakeview boulevard; fremont CA 94538
• MDR Report Key: 6990390
• MDR Text Key: 90700972
• Report Number: 6990390
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/13/2019
• Device Model Number: M00499120
• Device Catalogue Number: M00499120
• Device Lot Number: 20881358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1