BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIRMEDSURG

    MDR report key: 3111832 · Received May 7, 2013

    Report

    Report Number
    3010048749-2013-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MANUFACTURER ARJOHUNTLEIGH, INC. PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE KINETIC CONCEPTS, INC. AS OF NOVEMBER 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE NURSE: ON (B)(6) 2013, WHILE TRANSFERRING THE PATIENT ONTO THE BED, THE RIGHT LOWER WHEEL AND LEFT UPPER WHEEL ON THE BED FELL OFF. THERE WAS NO INJURY TO THE PATIENT OR MEDICAL STAFF. THE PATIENT WAS PLACED IN A CHAIR AND REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198168 KINAIRMEDSURG LOW AIR LOSS THERAPY IOQ ARJOHUNTLEIGH INC. 201001W

    Patients

    Seq Age Sex Outcome Treatment
    1