BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEDY

    MDR report key: 1971753 · Received January 12, 2011

    Report

    Report Number
    9681684-2011-00003
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PADDLES ON STEDY WERE STIFF TO USE. UPON INSPECTION, IT WAS FOUND THAT ROLL PINS ON BOTH SIDES HAD SHEARED CAUSING INTERNAL SCORING. NO PATIENT INVOLVED, NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEDY PATIENT, LIFT, NON AC POWERED FSA BHM MEDICAL, INC. NTA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other