BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER 600

    MDR report key: 2932418 · Received January 22, 2013

    Report

    Report Number
    9681684-2013-00004
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 12, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HEALTHCARE IS THE IMPORTER FOR THIS DEVICE, AND HAS SUBMITTED THE REPORT#2182305-2012-00041. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE IMPORTER OF THE DEVICE THAT AN INCIDENT OCCURRED INVOLVING A FLOOR LIFT. AS REPORTER TO THE IMPORTER BY THE FACILITY, THEY WERE JUST STARTING TO LIFT A RESIDENT WHEN THE BOLT THAT HOLDS THE SCALE ONTO THE CRADLE CAME OUT DROPPING THE RESIDENT. RESIDENT WAS NOT INJURED AND NO MEDICAL ATTENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31558 HOYER 600 MANUFACTURED FLOOR PASSIVE LIFT FSA ARJOHUNTLEIGH MAGOG INC 9600102.06

    Patients

    Seq Age Sex Outcome Treatment
    1