BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER 600

    MDR report key: 4743355 · Received April 30, 2015

    Report

    Report Number
    1419652-2015-00147
    Event Type
    Other
    Date Received
    April 30, 2015
    Date of Event
    October 25, 2014
    Report Date
    April 2, 2015
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 ARJOHUNTLEIGH RECEIVED THE FDA REPORT (B)(4) FROM (B)(4) THE US IMPORTER OF THE DEVICE. ON (B)(6) 2014 (B)(4) RECEIVED A REPORT FROM THE CUSTOMER REGARDING THE INCIDENT INVOLVING THE HOYER 600 LIFT AND THE SLING: ON (B)(6) 2014 THE SLING WAS PLACED TOO LOW. WHEN THE CERTIFIED NURSING ASSISTANT (CNA) THAT WAS GUIDING THE PT LET GO TO POSITION THE WHEELCHAIR UNDERNEATH HER, THE PT FELL BACKWARD OUT OF THE SLING. THE CNA ATTEMPTED TO CATCH THE PT, HOWEVER WAS ONLY SUCCESSFUL IN SLOWING THE FALL. THE PT BUMP THE HEAD BUT, OTHERWISE, HAD NO MARKS OR INJURIES. NEUROLOGICALLY, THE PT WAS AT HER BASELINE ABILITIES. THE PT THEN WAS SENT TO THE EMERGENCY ROOM FROM EVALUATION AND EVERYTHING WAS WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285338 HOYER 600 FSA ARJOHUNTLEIGH MAGOG INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other