BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAIR PRO - MODEL 6252

    MDR report key: 2931872 · Received January 28, 2013

    Report

    Report Number
    0001831750-2013-00450
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT FLIP-UP HANDLE HAD A SMALL BULGE IN THE ALUMINUM TUBE. THE BULGE WAS LOCATED APPROXIMATELY ONE INCH FROM THE END OF THE TUBE, NEAR THE CASTING WHICH IS PRESSED APPROXIMATELY 2 INCHES INTO THE TUBE. ON CUTTING OPEN THE HANDLE, IT WAS OBSERVED THAT THE BULGE WAS DUE TO A BURR OR CHIP OF ALUMINUM, LIKELY DEPOSITED BETWEEN THE CASTING AND TUBE DURING THE PRESS-FIT PROCESS. THIS WAS A COSMETIC ISSUE AND DID NOT HAVE ANY AFFECT ON THE FUNCTIONALITY OR PERFORMANCE OF THIS UNIT.

    Additional Manufacturer Narrative · 1

    FRAME WAS DENTED AND HANDLE WAS REPLACED. MANUFACTURER'S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED. DEVICE WAS EVALUATED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A DENT AT THE BOTTOM SIDE WHERE THE SLIDED SOLID ENDS AND THE HANDLE OF THE CHAIR HAS BEEN REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A DENT AT THE BOTTOM SIDE WHERE THE SLIDED SOLID ENDS AND THE HANDLE OF THE CHAIR HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37845 STAIR PRO - MODEL 6252 STRETCHER, HAND-CARRIED FPP STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1