MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC. ZONARE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

Upon connecting the view flex us catheter to the junction box, the catheter was not recognize by the zonare us machine.A second view flex catheter was then thrown on sterile table and then connected to junction box.That catheter was not recognized by the zonare us machine either.An acunav us catheter was thrown and the acunav machine set up.We proceded with procedure with the acunav without any further issues.A st.Jude rep called tech support, the issue is thought to be the transducer.The zonare us machine is tagged out of service.

• Brand Name: ZONARE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC.; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 4826906
• MDR Text Key: 21553885
• Report Number: 4826906
• Device Sequence Number: 1
• Product Code: IYO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2015
• Patient Sequence Number: 1
• Patient Age: 60 YR