BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIEWMATE¿ Z INTRACARDIAC ULTRASOUND SYSTEM

    MDR report key: 14102558 · Received April 13, 2022

    Report

    Report Number
    3004189859-2022-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    April 4, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ZONARE MEDICAL SYSTEMS, INC
    Product Code
    DRJ
    UDI-DI
    00541506701336
    PMA / PMN Number
    K151175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, G3, H2, H3, H4. REVIEW OF THE PROVIDED FSR FOUND THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY A REPRESENTATIVE FROM MINDRAY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED OUTPUT PROBLEM AND SUBSEQUENT DELAY REMAIN UNKNOWN.

    Description of Event or Problem · 0

    DURING THE PATENT FORAMEN OVALE (PFO) PROCEDURE, AN ERROR MESSAGE WAS NOTED STATING "IMAGING SYSTEM ERROR OCCURRED - RESETTING". THE IMAGE WAS STILL VISIBLE, BUT THE SCREEN WAS LAGGING. THE SYSTEM WAS REBOOTED, BUT THE ISSUE PERSISTED. THE PORT FOR THE ICE CATHETER WAS EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE ICE CATHETER WAS THEN REPLACED, BUT THE ISSUE REMAINED. THE SYSTEM WAS REBOOTED FOR A SECOND TIME AND THE IMAGE APPEARED NORMAL AND THE ERROR MESSAGE WAS CLEARED. TROUBLESHOOTING LEAD TO A 30 MINUTE PROCEDURAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788746 VIEWMATE¿ Z INTRACARDIAC ULTRASOUND SYSTEM SYSTEM, SIGNAL ISOLATION DRJ ZONARE MEDICAL SYSTEMS, INC H701336 665177 00541506701336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown