BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESIGNS VS4

    MDR report key: 8619133 · Received May 17, 2019

    Report

    Report Number
    8619133
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 27, 2019
    Report Date
    May 15, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WERE ADMITTED TO NEUROSURGERY AND NEUROLOGY SERVICE RESPECTIVELY. PORTABLE VITAL SIGN MONITOR (VS4) IN THEIR SEMI-PRIVATE PATIENT'S ROOM WAS FOUND TO BE SMOKING. PATIENTS WERE UNHARMED AND RELOCATED TO OTHER ROOMS. IT BURNED A HOLE IN THE PRIVACY CURTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414285 SURESIGNS VS4 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN PHILIPS MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA