BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALF POWER SUPERSTAND STANDUP WHEELCHAIR

    MDR report key: 1712829 · Received June 5, 2010

    Report

    Report Number
    3007494904-2008-00001
    Event Type
    Other
    Date Received
    June 5, 2010
    Date of Event
    June 4, 2008
    Report Date
    June 2, 2010
    Manufacturer
    THE STANDING COMPANY
    Product Code
    IPL
    PMA / PMN Number
    K032101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO OUR FACILITY ON 06/12/2008. DEVICE WAS INSPECTED. RECREATION OF EVENT ON (B) (6) 2008 AT DEVICE MFG FACILITY. UPON INVESTIGATION, IT WAS NOTED THAT THE SET SCREW ON THE ARM SWIVEL HOUSING, WHICH IS LOCTITED, THE LOCTITE DOES NOT ADHERE PROPERLY ONCE ARM ASSEMBLY IS INSTALLED WITH GREASE. DEVICE WAS REPLACED WITH NEW ARM ASSEMBLY. CORRECTIVE ACTION WAS GENERATED FROM INVESTIGATION. DEVICE WAS RETURNED TO PT (B) (6) IN (B) (6) 2008, WHERE HE WAS ABLE TO CONTINUE USE OF THE CHAIR. ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    PT'S MOM CALLED IN AND SAID THAT HER SON, PT: (B) (6), FELL OUT OF HIS STANDING WHEELCHAIR (MODEL: HPS-2, (B) (4)), AND HIT HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALF POWER SUPERSTAND STANDUP WHEELCHAIR STANDUP WHEELCHAIR IPL THE STANDING COMPANY HPS-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other HPS-2, 2 YRS OF USE| HALF POWER SUPERSTAND STANDUP WHEELCHAIR