MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3; SYSTEM, SIGNAL ISOLATION

Model Number	H701336
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem Description
Related manufacturing ref: 3008452825-2019-00561, 2184149-2019-00209.During a left atrial appendage closure procedure, the system displayed a "overheating error" message and the procedure was canceled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
One viewmate zs3, serial (b)(6), was returned for investigation.During the visual inspection of the system it was observed that the scan module was full of dust.The viewmate was connected to an external power source and the viewmate system was powered on.The error mentioned in the event description was able to be confirmed.The issue was isolated to insufficient cooling of the scan engine due to the dust collection.Cleaning the scan module properly resolved the issue.Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to an abnormal functioning scan engine caused by dust build up.

• Brand Name: VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3
• Common Device Name: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 9284089
• Report Number: 3004189859-2019-00003
• Device Sequence Number: 586450
• Product Code: DRJ
• UDI-Device Identifier: 05415067013361
• UDI-Public: 05415067013361
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K120703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H701336
• Device Catalogue Number: H701336
• Device Lot Number: 5254117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIEWFLEX ICE CATHETER; VIEWMATE CIM
• Outcome Attributed to Adverse Event: Other