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

Model Number	H701336
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
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.Further information was requested but not received.
Event or Problem Description
When the system was plugged in prior to a procedure, visible smoke was noted from the system.There was no patient involved.
Additional 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
• Common Device Name: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 10455364
• Report Number: 3004189859-2020-00005
• Device Sequence Number: 4283496
• Product Code: DRJ
• UDI-Device Identifier: 05415067013361
• UDI-Public: 05415067013361
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other