MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS VIVID; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number E9 BT11 AND BT12 TO BT13 XDCLEAR UPG

Device Problems Computer Software Problem (1112); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/07/2020

Event Type  malfunction  

Event Description

Patient was having a pre-ablation transesophageal echocardiography (tee).Tee performed and ok to proceed with ablation.Shut down echo machine in order to go back to echo lab.Upon starting machine back up and transmitting images, the machine malfunctioned and wouldn't send images.Service technician called in.The software was corrupt for unknown reason.Study was not able to be recovered.Images lost.

• Brand Name: VIVID
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 10419631
• MDR Text Key: 203315381
• Report Number: 10419631
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/11/2020,07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E9 BT11 AND BT12 TO BT13 XDCLEAR UPG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA