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

Model Number H701336

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event 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.

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
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 9284089
• MDR Text Key: 165420181
• Report Number: 3004189859-2019-00003
• Device Sequence Number: 1
• Product Code: DRJ
• UDI-Device Identifier: 05415067013361
• UDI-Public: 05415067013361
• Combination Product (y/n): N
• PMA/PMN Number: K120703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIEWFLEX ICE CATHETER; VIEWMATE CIM
• Patient Outcome(s): Other