BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPPIE VOYAGE

    MDR report key: 6918672 · Received October 5, 2017

    Report

    Report Number
    9616084-2017-00009
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 8, 2017
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    LBE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STROLLER WAS RECEIVED BY SUNRISE MEDICAL AND INSPECTED BY LEAD ENGINEER MANUAL R&D ON 10/3/2017. THE ORIGINAL SEATING SYSTEM WAS NOT RETURNED WITH THE STROLLER BASE, HOWEVER THE PARENT DID INDICATE IN THE COMPLAINT THAT THE LATCH MECHANISM WAS NOT BROKEN. HOWEVER, UPON REVIEW OF THE RETURNED BASE, IT WAS EVIDENT THAT THE ROTATIONAL LOCK ON THE SLIDE-N-LOCK MOUNTING PLATE WAS NOT FUNCTIONING PROPERLY. THIS ISSUE DOES NOT APPEAR TO BE RELATED TO THE REPORT OF "CATAPULTING" BUT IT MAY BE INDICATIVE OF LOADING THAT COULD HAVE DAMAGED THE LATCH SYSTEM EVEN IF THE PARENT DID NOT NOTICE THE FAILURE. BECAUSE THE SEATING SYSTEM WAS NOT RETURNED WITH THE BASE THE EVALUATION WAS CONDUCTED WITH A SEATING SYSTEM SIMILAR TO THE ONE THAT WOULD HAVE BEEN SHIPPED WITH THE CHAIR. DURING THE INVESTIGATION, WHEN THE SEAT WAS MOUNTED AND THE RED LOCKING MECHANISM WAS PROPERLY ENGAGED, THE SEAT WAS SECURE AND THERE WAS NO POTENTIAL FOR "CATAPULTING" WHEN THE SEAT WAS BROUGHT BACK TO ITS UPRIGHT POSITION FROM THE TILT POSITION. TO DETERMINE IF INCORRECT INSTALLATION OF THE SEATING SYSTEM COULD CONTRIBUTE TO THE DESCRIBED FAILURE, A TEST WAS CONDUCTED BY ACTIVATING THE LATCH LOCK SYSTEM PRIOR TO INSTALLING THE SEAT. THIS ALLOWS THE SEAT TO SIT ON THE SLIDE-N-LOCK PLATE BUT PREVENTS THE LATCH MECHANISM FROM ENGAGING. IN THIS CONDITION THE FAILURE MODE AS DESCRIBED IN THE COMPLAINT WAS ABLE TO BE REPEATED. THE POTENTIAL FOR FAILURE WILL BE DICTATED BY THE EFFECTIVENESS OF THE SEAT LATCH AND BY THE FORE/AFT LOADING OF THE SEAT. INSTRUCTIONS FOR INSTALLATION OF THE SEATING SHELL ARE EXPLAINED IN SECTION "I", POINT "E" OF THE THIRD PARAGRAPH OF THE SUNRISE MEDICAL, ZIPPIE VOYAGE OWNER'S MANUAL, TITLED "INSTALL THE SEATING SHELL" WHICH STATES, "SLIDE THE SEAT BACKWARDS EVENLY. YOU SHOULD HEAR AN AUDIBLE CLICK. CHECK THE SECURE ENGAGEMENT TO THE BASE BY PULLING UP ON BOTH SIDES. IF IT DOES NOT MOVE OR TILT, THE SEATING SHELL IS NOW LOCKED AND HAS BEEN INSTALLED PROPERLY." SUNRISE MEDICAL HAS DETERMINED THAT A SIMILAR EVENT IS UNLIKELY TO OCCUR WHEN THESE INSTALLATION STEPS ARE TAKEN.

    Description of Event or Problem · 1

    PER (B)(4), THE END USER'S MOTHER STATES THEY LAUNCHED AND MOVED THE RED LEVER AND WENT BACKWARDS FROM THE STEPS, WHEN THEY TURNED AROUND THE WHOLE SEATING SYSTEM "CATAPULTED" OFF OF THE BASE OF THE CHAIR AND THE CHILD FELL DIRECTLY ON THEIR HEAD. THE CHILD WAS TAKEN TO THE ER AS A PRECAUTION AND THE DOCTOR DID AN INITIAL EVALUATION. PER SALES REP (B)(4) HE WAS TOLD THAT THE DOCTOR DID NOT FEEL THERE WAS ANYTHING WRONG WITH THE CHILD AS THE CHILD WAS PLAYING AROUND AND PLAYING ON AN (B)(6). (B)(4) STATED THAT THE PARENTS DID DO A FEW TESTS ON THE STROLLER. THEY ATTEMPTED TO PULL THE CHAIR HARD TO SEE IF THEY WOULD BE ABLE TO PULL THE SEATING OFF AND SAID THAT IT WAS NOT MOVING. THE FATHER STATED HE MADE SURE THAT THE LATCH MECHANISM WAS NOT BROKEN. HE STATES THAT THE SHOULDER STRAPS HANG DOWN PRETTY FAR AND IS NOT SURE IF THEY POSSIBLY CAUSED INTERFERENCE WHEN PUTTING SYSTEM IN TO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695187 ZIPPIE VOYAGE STROLLER (CHAIR WITH CASTERS) LBE SUNRISE MEDICAL PRIVADA MISIONES EIZ4

    Patients

    Seq Age Sex Outcome Treatment
    1