BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS2+ NBP/SPO2

    MDR report key: 3007242 · Received February 20, 2013

    Report

    Report Number
    1218950-2013-00579
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 24, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    PMA / PMN Number
    K112652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE MONITOR WAS FREEZING UP. THE CUSTOMER STATED THAT THE MONITOR WAS IN USE WHEN THE ISSUE OCCURRED. NO PATIENT HARM WAS REPORTED. THIS IS BEING CONSIDERED REPORTABLE BECAUSE DURING A SCREEN FREEZE, REAL TIME MONITORING HAS STOPPED. ALARMS MAY NOT BE SOUNDED IF THEY OCCUR. THE CLINICIAN MIGHT BE TREATING AN OLD INFORMATION. THE PATIENTS' TRUE CONDITION MAY NOT BE REPORTED. IF THE PATIENT CONDITION WERE DETERIORATING, THERE IS POTENTIAL FOR SERIOUS INJURY. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR WAS FREEZING UP. THE CUSTOMER STATED THAT THE MONITOR WAS IN USE WHEN THE ISSUE OCCURRED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74170 SURESIGNS VS2+ NBP/SPO2 DXN PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1