BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPORT CHAIR

    MDR report key: 2507532 · Received March 22, 2012

    Report

    Report Number
    1417592-2012-00013
    Event Type
    Other
    Date Received
    March 22, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 20, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER ATTEMPTED TO SIT DOWN ON THE CHAIR AND IT ROLLED BACK. IT IS NOT KNOW IF SHE ACTUALLY FELL OR WAS CAUGHT BY HER CAREGIVER. SHE WAS EVALUATED IN THE ER FOR CHEST PAIN. A T11 FRACTURE WAS IDENTIFIED VIA CHEST X-RAY. SHE HAS A HISTORY OF OSTEOPOROSIS AND OTHER SPINAL FRACTURES. THE SON STATED HE DID NOT KNOW IF THE T11 FRACTURE RESULTED FROM THIS INCIDENT. SHE RECEIVED A STEROID INJECTION FOR BACK PAIN. NO OTHER TREATMENT WAS INITIATED. THE SON REPORTED THERE HAD BEEN SPORADIC BRAKE ISSUES DURING THE PREVIOUS MONTHS BUT THEY CONTINUED TO USE THE DEVICE . HE ALSO NOTED THAT A NUT WAS MISSING FROM THE LEFT BRAKE LEVER. THE SAMPLE WAS RETURNED AND EVALUATED. THE SEAT SUPPORT TUBES WERE BENT AND THE NUT THAT HOLDS THE TOP PIVOTING BRAKE LEVEL WAS MISSING AND AS A RESULT, THE BRAKE HANDLE WAS BENT. WEAR ON THE HANDLE INDICATES THAT THE NUT WAS IN PLACE AT ONE TIME. IT IS NOT KNOWN WHEN IT CAME OFF. THE MISSING NUT MAKES THE BRAKE MORE DIFFICULT TO LOCK, ALTHOUGH ONCE LOCKED, IT WAS FULLY FUNCTIONAL AND PREVENTED THE ROTATION OF THE WHEEL. THE SAMPLE EVALUATION DID NOT IDENTIFY ANY MFG DEFECT. THE OVERALL WEAR OF THE CHAIR SUGGESTS IT WAS NOT MAINTAINED WHICH IS THE LIKELY ROOT CAUSE OF THE DAMAGES TO THE DEVICE AND A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE CHAIR ROLL BACKWARDS AS THE END USER WENT TO SIT DOWN AND SHE FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPORT CHAIR INM MEDLINE INDUSTRIES, INC. MDS808200W

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other