BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 1.5T

    MDR report key: 3223359 · Received July 10, 2013

    Report

    Report Number
    3003768277-2013-00035
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K001987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: THE OBSERVED INJURY ON THE ARM IS CONSISTENT WITH HEATING INCIDENTS CAUSED BY A LACK OF DISTANCE AND PADDING BETWEEN THE CABLE AND PATIENT'S SKIN (THE INSTRUCTIONS FOR USE CLEARLY INDICATE A MINIMUM DISTANCE OF 2 CM). THE PATIENT WAS SEDATED, WHICH COULD EXPLAIN THE SERIOUSNESS OF THE OBSERVED INJURIES AS THIS INFLUENCES THE HEAT CAPACITY OF THE SKIN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS EXAMINED FEET FIRST FOR AN EXAMINATION OF THE PELVIS USING THE SENSE BODY COIL. TWO HOURS AFTER THE EXAMINATION A BLISTER WAS REPORTED BY THE REFERRING HOSPITAL. THE PATIENT WAS AN OUTPATIENT FOR OUR CUSTOMER AND THE EXACT SIZE OF THE BLISTER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317665 INTERA 1.5T LNH PHILIPS HEALTHCARE 781195

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other