MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 6VT-D

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/22/2020

Event Type  malfunction  

Event Description

The tee probe failed the electrical leak test one day, it was not taken out of service, and used on another patient on another day.

Event Description

The tee probe failed the electrical leak test one day, it was not taken out of service, and used on another patient on another day.

• Brand Name: NA
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 10441897
• MDR Text Key: 204007182
• Report Number: 10441897
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

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: No Information
• Device Model Number: 6VT-D
• Device Catalogue Number: REF # KN100120
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Device Age: 1 YR
• Date Report to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2020
• Patient Sequence Number: 1
• Patient Age: 27010 DA