BEUDAMED
    FDA Adverse Event Summary report: N

    APOLLO WHIRLPOOL BATH

    MDR report key: 6012045 · Received October 7, 2016

    Report

    Report Number
    2182947-2016-00001
    Date Received
    October 7, 2016
    Date of Event
    May 23, 2016
    Report Date
    June 16, 2016
    Manufacturer
    APOLLO CORPORATION
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH INVESTIGATING THE INCIDENT IT WAS DETERMINED THAT THE DEVICE WAS USED BY INDIVIDUALS WITHOUT PROPER TRAINING PRIOR TO THE EVENT. THE CHAIR WAS LIKELY REMOVED FROM THE REST OF THE DEVICE FOR CLEANING AND PLACED ON TOP OF THE LOWER SECTION OF THE CARRIER AS OPPOSED TO INTERFACING THE CHAIR'S BEARINGS WITH THE RAILS PROPERLY. DUE TO THIS THE CHAIR'S GUARDS LOCATED UNDER THE BEARINGS WERE RESTING ON THE RAILS INSTEAD OF UNDER THEM WHERE THEY WOULD HAVE WORKED WITH THE BEARINGS TO SECURE THE CHAIR IN PLACE. THE INCIDENT OCCURRED AS THE PATIENT SHIFTED TO THE SIDE AND THUS CAUSED THE CHAIR TO SHIFT AND FALL BETWEEN THE RAILS.

    Description of Event or Problem · 1

    PATIENT FELL FROM TRANSFER DEVICE CHAIR AND SUFFERED CONTUSION REQUIRING STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662897 APOLLO WHIRLPOOL BATH BATH CHAIR ILJ APOLLO CORPORATION 6000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization