BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 1930249 · Received November 18, 2010

    Report

    Report Number
    9681684-2010-00048
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE AIDE WAS TRANSFERRING A PT FROM THE BED TO THE CHAIR, THE CLIP ON THE SLING DISCONNECTED FROM THE LIFT, CAUSING THE PT TO SLIDE OUT HEAD FIRST. THE PT FELL ABOUT ONE FOOT AND HIT THE LEFT SIDE OF HER HEAD. SHE WAS RUSHED TO THE HOSP BUT FROM THE BEST KNOWLEDGE OF THE CUSTOMER, DID NOT SUSTAIN ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO MANUFACTURED FLOOR PASSIVE LIFT FSA BHM MEDICAL, INC. KPB5100

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O