BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WESCOM PATIENT STATION MODEL MEDLINK #SPS-3000

    MDR report key: 3144870 · Received May 28, 2013

    Report

    Report Number
    MW5030363
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CRITICAL ALERT, INC. - FORMERLY WESCOM
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMOKE AND A "BURNING SMELL" WERE DETECTED COMING FROM A (B)(4) PT STATION MEDLINK MODEL SPS-3000. PT NOT EFFECTED OTHER THAN MOVING TO ANOTHER ROOM. NO DAMAGE OUTSIDE OF WALL UNTIL OTHER THAN SMOKE AND ODOR. A PRESSBOARD INSERT AND THE CIRCUIT BOARD INSIDE THE UNIT SUSTAINED BURN/MELTING DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232992 WESCOM PATIENT STATION MODEL MEDLINK #SPS-3000 WESOM MEDLINK NURSE CALL STATION ILQ CRITICAL ALERT, INC. - FORMERLY WESCOM SPS 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR