BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLVE

    MDR report key: 3820949 · Received April 15, 2014

    Report

    Report Number
    3010048749-2014-00051
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH: THERE ARE TWO EVOLVE MATTRESSES THAT APPEAR TO HAVE A DEFLATED AREA. THERE WERE NO INJURIES ASSOCIATED WITH THIS COMPLAINT. IF THIS TYPE OF MALFUNCTION WERE TO RECUR, IT MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR MEDICAL INTERVENTION TO PREVENT HARM. THEREFORE, THIS EVENT IS REPORTABLE. THIS IS NUMBER ONE OF TWO COMPLAINTS FOR THIS MALFUNCTION FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230546 EVOLVE IKY ARJOHUNTLEIGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1