BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 6000695 · Received October 5, 2016

    Report

    Report Number
    1051786-2016-00013
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 30, 2016
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT RECEIVED A BURN INJURY ON THE LOWER LEFT LEG. THE PATIENT WAS REPORTEDLY BEING MONITORED WITH THE DEVICE. THE PATIENT WAS POSITIONED HEAD FIRST SUPINE TO UNDERGO MRI EXAMINATION OF THE BRAIN. SHORTLY AFTER THE EXAMINATION, AN 8 CM LARGE RED AREA WITH A 3 CM BLISTER WAS OBSERVED ON THE PATIENT ON THE INSIDE OF THE LEFT LOWER LEG OF THE PATIENT. THERE IS PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT RECEIVED A BURN INJURY ON THE LOWER LEFT LEG. THE PATIENT WAS REPORTEDLY BEING MONITORED WITH THE DEVICE. THE PATIENT WAS POSITIONED HEAD FIRST SUPINE TO UNDERGO MRI EXAMINATION OF THE BRAIN. SHORTLY AFTER THE EXAMINATION, AN 8 CM LARGE RED AREA WITH A 3 CM BLISTER WAS OBSERVED ON THE PATIENT ON THE INSIDE OF THE LEFT LOWER LEG OF THE PATIENT. THE PATIENT WAS TREATED WITH BASIC STANDARD NURSERY CARE AND MONITORING FOLLOWING THE INCIDENT. THIS IS NOT CONSIDERED TO BE EMERGENT TREATMENT AND THEREFORE, THIS IS NOT CONSIDERED TO BE A SERIOUS INJURY. REFER TO (B)(4) FOR THE INVESTIGATION RELATED TO THE DS HEAD COIL AND INGENIA 1.5T SYSTEM. THE CUSTOMER REPORTED THAT A PATIENT RECEIVED A BURN INJURY ON THE LOWER LEFT LEG. THE PATIENT WAS TREATED WITH BASIC STANDARD NURSERY CARE AND MONITORING FOLLOWING THE INCIDENT. THIS IS NOT CONSIDERED TO BE EMERGENT TREATMENT AND THEREFORE, THIS IS NOT CONSIDERED TO BE A SERIOUS INJURY. THE DEVICE WAS BEING USED FOR PATIENT MONITORING DURING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653050 INVIVO CORPORATION PATIENT MONITOR MWI INVIVO CORPORATION 865323

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other