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

Model Number H701336

Device Problem Output Problem (3005)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

During the patent foramen ovale (pfo) procedure, an error message was noted stating "imaging system error occurred - resetting".The image was still visible, but the screen was lagging.The system was rebooted, but the issue persisted.The port for the ice catheter was exchanged which did not resolve the issue.The ice catheter was then replaced, but the issue remained.The system was rebooted for a second time and the image appeared normal and the error message was cleared.Troubleshooting lead to a 30 minute procedural delay.The procedure was successfully completed with no adverse patient consequences.

Manufacturer Narrative

Additional information: d4, g3, h2, h3, h4.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 output problem and subsequent delay remain unknown.

• Brand Name: VIEWMATE¿ Z INTRACARDIAC ULTRASOUND SYSTEM
• 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: 14102558
• MDR Text Key: 289192788
• Report Number: 3004189859-2022-00001
• Device Sequence Number: 1
• Product Code: DRJ
• UDI-Device Identifier: 00541506701336
• UDI-Public: 0541506701336
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/14/2022

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
• Device Model Number: H701336
• Device Lot Number: 665177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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