BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND 5000

    MDR report key: 2857690 · Received November 19, 2012

    Report

    Report Number
    2183634-2012-00003
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    IKX
    PMA / PMN Number
    K885343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRAULIC ACTUATOR WAS REPLACED BY TECHNICIANS AT (B)(6). DUE TO THE LACK OF INFO REGARDING THE INCIDENT, WE ARE UNABLE TO IDENTIFY ROOT CAUSE OF THE PROBLEM AT THIS TIME. THE PT HAS NOT SUFFERED ANY KIND OF PHYSICAL INJURY AS A RESULT OF THE INCIDENT. ALTIMATE MEDICAL REQUESTED TO HAVE THE HYDRAULIC ACTUATOR SHIPPED BACK TO OUR FACILITY FOR FURTHER EVAL. IF ADDITIONAL INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 ALTIMATE MEDICAL RECEIVED AN EMAIL FROM AN INTERNATIONAL SALES REP, REGARDING AN EASYSTAND 5000 WHICH STATED THE FOLLOWING: ACCORDING TO THE OCCUPATIONAL THERAPIST, THE HEALTHCARE STAFF WERE UNABLE TO LOWER THE USER FROM THE STANDING DEVICE BACK INTO A SEATED POSITION. THEREFORE, THEY ENDED UP MANUALLY DISASSEMBLING THE PRODUCT IN ORDER TO GET THE PT OUT OF THE STANDER. THE PT WAS SHAKEN BY THE INCIDENT, BUT UNHARMED PHYSICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND 5000 890.5370 IKX ALTIMATE MEDICAL, INC. 5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other