BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV

    MDR report key: 2275670 · Received September 19, 2011

    Report

    Report Number
    2183634-2011-00006
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 23, 2011
    Report Date
    September 16, 2011
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURN AUTHORIZATION HAS BEEN ISSUED FOR THE BASE TO BE RETURNED, BUT AS OF THE DATE OF THIS REPORT THE BASE HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    ON (B)(6), CUSTOMER SVC RECEIVED A PHONE CALL FROM A MEDICAL EQUIPMENT DEALER STATING THAT HE NEEDED TO ORDER A REPLACEMENT BASE AND REAR CASTERS FOR AN EASYSTAND. HE STATED THAT THE CASTER HAD BROKEN OFF AND THEY WERE UNABLE TO REMOVE THE STEM FROM THE BASE. ON (B)(6) 2011, I SPOKE WITH THE CONTACT AT THE MEDICAL EQUIPMENT DEALER ASKING IF HE HAD ANY FURTHER INFO REGARDING HOW THE CASTER HAD BROKEN AND/OR THE USER AND HE SAID HE DID NOT. HE STATED HE RECEIVED A CALL FROM HIS CUSTOMER THAT A PART WAS BROKEN AND WHEN HE WENT OUT TO THE HOME HE SAW THAT THE CASTER AND BROKE OFF FROM THE FRAME. I ASKED HIM TO TRY TO GET MORE INFO WHEN HE REPLACES THE COMPONENTS AND HE SAID IF HE RECEIVES ANY FURTHER INFO HE WILL CONTACT ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND EVOLV 890.3110 INO ALTIMATE MEDICAL, INC. EVOLV ADULT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other