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

Model Number H701336

Device Problem Smoking (1585)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Further information was requested but not received.

Event Description

When the system was plugged in prior to a procedure, visible smoke was noted from the system.There was no patient involved.

Manufacturer Narrative

The device was received at the vendor for analysis.Based on the information provided to abbott and the investigation performed, the cause for the reported event was isolated to the console scan engine.The device history record was reviewed, no issues were noted.

• 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: 10455364
• MDR Text Key: 204410787
• Report Number: 3004189859-2020-00005
• Device Sequence Number: 1
• Product Code: DRJ
• UDI-Device Identifier: 05415067013361
• UDI-Public: 05415067013361
• Combination Product (y/n): N
• PMA/PMN Number: K151175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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: 7199207
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other