MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ Z TRANSESPHAGEAL TRANSDUCER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 100042294

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  Injury  

Event Description

During the procedure, artifact was noted on the system while using the tee probe and a clinically significant delay occurred.After observing the artifact on the system, the probe and system were replaced resulting in a 30 minute delay and the patient needed to be intubated a second time.The procedure was completed with the replacement system with no adverse consequences to the patient.

Manufacturer Narrative

The reported device was not returned for investigation but following service at the customer site, replacing the ac power cord corrected the issue.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, the cause for the reported artifact and subsequent procedure delay was due to the filter ac power cord.

• Brand Name: VIEWMATE¿ Z TRANSESPHAGEAL TRANSDUCER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 8243802
• MDR Text Key: 132924823
• Report Number: 3004189859-2019-00001
• Device Sequence Number: 1
• Product Code: ITX
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100042294
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1