MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ Z INTRACARDIAC CONSOLE WITH BATTERY PACK; ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

Model Number 100044271

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Event Description

Prior to a proximal atrial fibrillation procedure, the viewmate z system displayed an internal system error and would not function properly which lead to cancellation of the procedure.There were no adverse consequences to the patient as the procedure had not yet started.The procedure was cancelled due to the inability of the system to startup properly.

Manufacturer Narrative

Based on the information provided to abbott and the investigation performed, the cause for the reported cancellation was due to the malfunction of the z.One scanner.The analog and the power boards were replaced in the scanner which resolved the issue.

• Brand Name: VIEWMATE¿ Z INTRACARDIAC CONSOLE WITH BATTERY PACK
• Type of Device: ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6741015
• MDR Text Key: 81134316
• Report Number: 3004189859-2017-00001
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100044271
• Other Device ID Number: 05415067015501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1