BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXISKY 600

    MDR report key: 2607707 · Received May 31, 2012

    Report

    Report Number
    9681684-2012-00043
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 2, 2012
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) ON BEHALF OF THE MFR ARJOHUNTLEIGH MAGOG INC (B)(4). MFR COMPLAINT NUMBER: (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    A DISPOSABLE, REPOSITIONING SLING WAS BEING USED WITH A CEILING LIFT TO HOLD THE BACK OF THE PT UP FOR A CHEST X-RAY, WHEN THE SLING RIPPED. THE ACTIVITY WAS STOPPED. NO INJURIES WERE SUSTAINED BY EITHER THE PT OR THE CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FSA ARJOHUNTLEIGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1