MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE VIEWMATE Z W/SCAN ENGINE CART AND BATTERY; SYSTEM, SIGNAL ISOLATION

Model Number 100044271

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Prior to the procedure, while the patient was prepped and sedated, there was an internal system error upon boot up.The procedure was cancelled as they were not able to use the viewflex to go transseptal.There were no adverse patient consequences due to this event.

Manufacturer Narrative

One viewmate engine was received for analysis.Investigation determined that the cause of the malfunction was the analog board module.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 investigation performed the cause of the reported event was faulty analog board.

• Brand Name: VIEWMATE VIEWMATE Z W/SCAN ENGINE CART AND BATTERY
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 10960064
• MDR Text Key: 219956928
• Report Number: 3004189859-2020-00006
• Device Sequence Number: 1
• Product Code: DRJ
• 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: 02/16/2021

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: 100044271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other