BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE RYTHM

    MDR report key: 2050972 · Received April 4, 2011

    Report

    Report Number
    2937137-2011-00007
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER WAS ISSUED A RMA TO RETURN THE AFFECTED PARTS SO WE DO ANTICIPATE AN EVAL BY OUR FAILURE INVESTIGATOR ONCE WE RECEIVE THE PARTS FROM THE DEALER. WE WILL SUBMIT A F/U REPORT ONCE THE EVAL AND INVESTIGATION IS FINALIZED. THE WHEELCHAIR HAS NOT BEEN RETURNED TO THE MFR FOR EVAL AND IT IS UNK IF OR WHEN THE MFR MAY HAVE AN OPPORTUNITY TO EVALUATE THE DEVICE. MFR DOES NOT HAVE ALL OF THE DETAILS OF THE REPORTABLE EVENT AT THIS TIME TO COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 1

    AN AUTHORIZED DEALER CONTACTED SUNRISE MEDICAL (B)(4) ON (B)(6) 2011 AND REPORTED THAT HIS CLIENT CLAIMED TO HAVE FALLEN FROM HER WHEELCHAIR ON (B)(6) 2011 CAUSING A SERIOUS INJURY. THE ALLEGED SERIOUS INJURY SUSTAINED WAS A BROKEN HIP. THE DEALER DID NOT ASK OR WAS NOT TOLD BY THE END USER WHAT SHE WAS DOING WHEN THE ALLEGED INCIDENT OCCURRED OR WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED ADVERSE EVENT. THE DEALER COMPLETED A VISUAL EXAMINATION OF THE WHEELCHAIR AND FOUND THAT BOTH CABLES FOR THE ANTI PITCH WERE BROKEN. DEALER REQUESTED QUOTES FOR THE REPLACEMENT PARTS TO COMPLETE REPAIRS TO THE END USER'S WHEELCHAIR. THE DEALER DID NOT PROVIDE THE END USER'S CONTACT INFO. DEALER STATED THAT HE SUSPECTED THAT ONE CABLE MAY HAVE BROKEN EARLIER AND THE CLIENT CONTINUED TO USE THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE RYTHM WHEELCHAIR, POWERED/ITI ITI SUNRISE MEDICAL (US) LLC. EIPW10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention