BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHYTHM

    MDR report key: 1910457 · Received November 18, 2010

    Report

    Report Number
    2937137-2010-00021
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 25, 2010
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RA/QA SPECIALIST REVIEWED THE COMPLAINT AND ALSO HAD AN INTERNAL SR QUALITY ENGINEER REVIEW THE COMPLAINT. THE CHAIR WAS SHIPPED WITH A "SWITCH IT" BRAND PROPORTIONAL HEAD CONTROL. SUNRISE MEDICAL (US) LLC DOES NOT MANUFACTURE "SWITCH IT" DEVICE, BUT (B)(4) DISTRIBUTES IT UPON REQUEST OF DEALERS. THE QUALITY ENGINEER AND RA/QA SPECIALIST ARE NOT AWARE OF ANY SIMILAR INCIDENTS OR COMPLAINTS IN WHICH WATER CAUSED A WHEELCHAIR TO MOVE UNEXPECTEDLY WITH MOTION THAT WAS NOT COMMANDED BY THE END USER. THE WHEELCHAIR HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND IT IS UNK IF OR WHEN THE MANUFACTURER MAY HAVE AN OPPORTUNITY TO EVALUATE THE DEVICE. MANUFACTURER DOES NOT HAVE ALL OF THE DETAILS OF THE REPORTABLE EVENT AT THIS TIME TO COMPLETE OUR INVESTIGATION. THE "SWITCH IT" DEVICE IS NOT MANUFACTURED BY SUNRISE MEDICAL (US) LLC.

    Description of Event or Problem · 1

    DEALER CALLED IN ON (B)(6) 2010, AND CLAIMS THE END USER CALLED HIM AND SAID THAT THE WHEELCHAIR TOOK OFF ON ITS OWN. THE END USER ALLEGES THAT WHEN THE WHEELCHAIR ACCELERATED FORWARD HE WAS EJECTED FROM THE WHEELCHAIR CAUSING HIM TO HIT HIS HEAD ON THE FLOOR. HE ALLEGES HIS HEAD WAS CUT OPEN. END USER CLAIMS AN AMBULANCE WAS CALLED AND HE WAS TRANSPORTED TO THE EMERGENCY ROOM AT THE HOSPITAL. HE STATED THAT HE NEEDED SEVEN STITCHES TO CLOSE HIS WOUND FROM THE HEAD INJURY HE SUSTAINED. END USER CLAIMS HE JUST GOT OUT OF THE BATH TUB OR SHOWER RIGHT BEFORE THE INCIDENT OCCURRED. HE THEN SAID HE GOT INTO THE WHEELCHAIR AND STARTED DRIVING. END USER UTILIZES A "SWITCH IT" HEAD CONTROL TO OPERATE THE POWER WHEELCHAIR. END USER IS NOT SURE IF HE GOT THE HEAD CONTROL WET OR NOT. DEALER DID A MAINTENANCE CHECK ON THE CHAIR AFTER THE INCIDENT AND STATED THE WHEELCHAIR IS WORKING PROPERLY. END USER IS STILL USING THE WHEELCHAIR AND HAS NOT HAD ANY INCIDENTS SINCE. THE ALLEGED INCIDENT TOOK PLACE ON (B)(6) 2010 OVER THE WEEKEND. END USER HAS REQUESTED AN EMERGENCY STOP SWITCH. END USER ALSO STATED HE IS OK NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHYTHM WHEELCHAIR, POWER ITI SUNRISE MEDICAL (US) LLC EIPW10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization