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

Model Number H701336

Device Problem Tactile Prompts/Feedback (4022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a procedure, when the viewmate system was started, the console keys were not working as the patient information could not be entered.When the catheter was connected, it would not register.The system was power cycled, the probes were replaced, and the battery was re-inserted, but the issue remained.The procedure was ultimately continued by switching to tee imaging, but this transition required increased sedation time for the patient.There were no adverse consequences to the patient.

Manufacturer Narrative

Investigation determined that the cause of the malfunction was the user interface.The user interface was replaced, and the unit passed all required tests.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the cause for the reported event was "user interface".

• 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: 9577319
• MDR Text Key: 174702810
• Report Number: 3004189859-2020-00001
• 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: 01/21/2020

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: 5333597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other