BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURVEYOR CENTRAL

    MDR report key: 6708925 · Received July 12, 2017

    Report

    Report Number
    2183461-2017-00006
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Report Date
    July 12, 2017
    Manufacturer
    MORTARA INSTRUMENT INC
    Product Code
    MHX
    PMA / PMN Number
    K060135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT WAS ON AN UNREPORTED DATE IN (B)(6) 2017. THE USER FACILITY HAS STATED THAT THE DEVICE IS AVAILABLE FOR EVALUATION. MORTARA HAS NOT RECEIVED THE DEVICE AT THE TIME OF THIS REPORT. FOLLOWING OUR EVALUATION OF THE RETURNED DEVICE OR IF ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON THE SURVEYOR CENTRAL PATIENT MONITOR SYSTEM WENT BLANK TWICE WITHOUT ANY ALARMS OR ERROR MESSAGES. THE REPORTED EVENT WAS ASSOCIATED WITH LOSS OF PATIENT DATA. IT WAS NOT REPORTED IF THERE WAS MORE THAN ONE PATIENT BEING MONITORED WHEN THE EVENT HAPPENED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR DEATH IN ANY PATIENT RELATED TO THIS EVENT. THE CUSTOMER REBOOTED THE SYSTEM BOTH TIMES AND REGAINED BACK THE MONITORING FUNCTION. THERE WAS NO REPORT OF ANY SUBSEQUENT PROBLEMS WITH MONITORING FOLLOWING THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488187 SURVEYOR CENTRAL SURVEYOR CENTRAL MHX MORTARA INSTRUMENT INC SCNODE-DAA-BXXBX NA

    Patients

    Seq Age Sex Outcome Treatment
    1