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

Model Number H701336

Device Problem Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2020

Event Type  Injury  

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 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 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.

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.

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
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 9963293
• MDR Text Key: 187779837
• Report Number: 3004189859-2020-00003
• 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,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 04/15/2020; 06/09/2020; 02/25/2021
• Supplement Dates FDA Received: 05/08/2020; 06/28/2020; 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other