BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSCAN-4

    MDR report key: 4293219 · Received November 21, 2014

    Report

    Report Number
    2919016-2014-00044
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIEMENS SERVICE ENGINEER REPLACED THE POWER SUPPLY BOARD, A/D BOARD AND ADJUSTED THE INSTRUMENT AS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER SMELLED SOMETHING BURNING FROM THE INSTRUMENT; HOWEVER, THE EXTERIOR OF THE INSTRUMENT WAS NOT HOT TO THE TOUCH. THE INSTRUMENT'S DRAWER WAS OPEN. THE CUSTOMER TRIED TO CLOSE THE DRAWER BY GOING THRU THE SOFTWARE AS IF RUNNING A PANEL AND 5 TO 10 MINUTES LATER OBSERVED POSSIBLY WHITE SMOKE EMITTING FROM THE INSTRUMENT THROUGH THE DRAWER OPENING. THE INSTRUMENT WAS NOT POWERED BUT THE POWER CORD WAS DISCONNECTED FROM THE ELECTRICAL SOURCE. ALTHOUGH THE SMOKING ISSUE DID NOT SET OFF ANY FIRE ALARMS, A CODE RED WAS ISSUED TO INDICATE AN EMERGENCY. IT WAS ALSO REPORTED THAT THE SMOKE DID NOT FILL THE ROOM BUT IT AGGRAVATED THE USER'S EXISTING COUGH. MEDICAL INTERVENTION WAS NOT REQUIRED. THE HOSPITAL'S BIOMED PERSONNEL REMOVED THE INSTRUMENT FROM THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758521 AUTOSCAN-4 AUTOSCAN-4 JWY SIEMENS HEALTHCARE DIAGNOSTICS B1012-1R NA

    Patients

    Seq Age Sex Outcome Treatment
    1