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

Model Number	H701336
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event was requested but not received.
Event or Problem Description
During device preparation, when the viewmate was powered on, the screen froze with a logo mark and did not proceed further.It took a longer time to forcibly shut down the device to resolve the issue.It is not known if the delay was clinically significant.The procedure was then completed without replacing the device and there were no adverse consequences to the patient.
Event or Problem Description
It was confirmed the freeze issue occurred prior to the patient entering the room and no patient was involved.Therefore there was no clinically significant delay.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.The device history record (dhr) for the unit involved in the report was reviewed, no issues were noted.
Additional Manufacturer Narrative
One viewmate¿ z ultrasound console battery zs3 was received for investigation.Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to the module receiver board.The board required replacement.The device history record (dhr) for the unit involved in the report 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: 9963293
• Report Number: 3004189859-2020-00003
• Device Sequence Number: 3116196
• Product Code: DRJ
• UDI-Device Identifier: 05415067013361
• UDI-Public: 05415067013361
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/01/2021

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: 6996615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/15/2020; 06/09/2020; 02/25/2021
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/08/2020; 06/28/2020; 03/01/2021
• 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