MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO.,LTD. VIVID IQ; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number VIVID IQ R1R2 TO R3 UPG

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Ice machine (vivid iq) not working when needed at the started of a procedure.After calling several people to trouble shoot, the machine had a work order placed.There were no other machines available.

• Brand Name: VIVID IQ
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO.,LTD.; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 12827697
• MDR Text Key: 280885707
• Report Number: 12827697
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2021,11/05/2021

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 Model Number: VIVID IQ R1R2 TO R3 UPG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male