BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VSI - NBP/SPO2

    MDR report key: 11715237 · Received April 23, 2021

    Report

    Report Number
    1218950-2020-07206
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Report Date
    April 3, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXN
    PMA / PMN Number
    K112652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE WITH THE CUSTOMER AND CONFIRMED THE ISSUE. THERE IS AN IMPACT ON THE FRONT PANEL AND A BLACK SPOT ON THE LCD SCREEN. THE RCE PROVIDED THE INFORMATION TO SEND THE DEVICE TO WORKSHOP. THERE WAS NO ADDITIONAL INFORMATION REGARDING THIS EVALUATION. IT IS UNKNOWN IF THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE, OR HOW THE ISSUE WAS RESOLVED. THERE HAVE BEEN NO SUBSEQUENT CALLS LOGGED FOR THIS DEVICE/ISSUE. THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF PREVIOUSLY CLOSED SERVICE ORDERS THAT WERE RECLASSIFIED AS COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPARENTLY THE DEVICE HAS FALLEN. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617655 SURESIGNS VSI - NBP/SPO2 PATIENT MONITOR DXN PHILIPS MEDICAL SYSTEMS 863276

    Patients

    Seq Age Sex Outcome Treatment
    1