MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ Z INTRACARDIAC CONSOLE; SYSTEM, SIGNAL ISOLATION

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Following a patent foramen ovale (pfo) closure case, the images froze causing a delay.The system was used with the p4-1c probe to perform a transthoracic echo as the usual echo machines were not available and the viewmate was in the lab.There was delay due to the image freezing between pressing ¿color¿ and the ¿2d¿ buttons and switching to that mode.The color mode was unable to be visualized due to the delay, but the device could be visualized and the procedure continued with no consequences to the patient.

Manufacturer Narrative

Review of the provided fsr found the results of the investigation are inconclusive as the device was not returned for analysis.The device history record review was completed by a representative from mindray.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported display issue and subsequent delay remains unknown.

• Brand Name: VIEWMATE¿ Z INTRACARDIAC CONSOLE
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• Manufacturer (Section G): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14307764
• MDR Text Key: 291377834
• Report Number: 3004189859-2022-00002
• Device Sequence Number: 1
• Product Code: DRJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1