BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 1000

    MDR report key: 2110952 · Received February 22, 2011

    Report

    Report Number
    9681684-2011-00015
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS, THIS WAS FOUND TO BE A REPORTABLE EVENT. FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    PER THE ARJOHUNTLEIGH TECH'S COMMENTS: " I FINISHED WITH THE REPAIRS BHM REQUESTED (REPLACEMENT OF PCB SUPPLIED BY BHM). I PUT THE LIFT BACK UP ON THE TRACK AND STARTED TO TEST THE MAXI SKY 1000 WITHOUT WEIGHT WHEN I STARTED TO SMELL SMOKE. I PULLED THE RED CORD AND THAT DID NOT MAKE A DIFFERENCE. I WENT UP THE LADDER AND STARTED TO TAKE OFF THE COVER. BY THIS TIME SMOKE WAS COMING FROM THE LIFT AND IT WAS HOT. I PULLED BACK THE COVER AND REACHED IN AND PULLED THE WIRES OFF THE PCB. WHEN I REMOVED THE LIFT FROM THE TRACK ON THE CEILING IT WAS ON FIRE. I PUT OUT THE FIRE AND REMOVED THE WIRES FROM THE BATTERIES. THE WIRES AND THE BATTERIES WERE NOT HOT, BUT THE SLAVE MOTOR WAS SO HOT YOU COULD NOT TOUCH IT AND THE SLAVE BOARD WAS BURNT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI SKY 1000 MANUFACTURED CEILING FIXED CASSETTES FNG BHM MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other