BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLVE

    MDR report key: 3820195 · Received April 1, 2014

    Report

    Report Number
    3010048749-2014-00030
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ARJOHUNTLEIGH, INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE KINETIC CONCEPTS, INC. AS OF (B)(4) 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. 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 BY THE ARJOHUNTLEIGH ACCOUNT EXECUTIVE (AE): IN (B)(6) 2013, (B)(4) EVOLVE MATTRESSES WERE PURCHASED BY THE FACILITY FOR A NEW INTENSIVE CARE UNIT THAT WOULD BE OPENED ON (B)(4) 2013. PRESENTLY ALL (B)(4) MATTRESSES ARE VISIBLY DEPRESSED IN THE CENTER. THE PATIENTS THAT WERE ON THE MATTRESSES WERE COMPLAINING THAT THE DEPRESSION IN THE MATTRESSES MADE CHANGING POSITIONS DIFFICULT AS WELL AS MAKING THE MATTRESSES UNCOMFORTABLE. WHEN THE AE INSPECTED THE MATTRESSES, THE HELIX PODS WERE VISIBLY COMPRESSED AND LOW. IF THIS MALFUNCTION WERE TO RECUR, IT MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR MEDICAL INTERVENTION TO PREVENT HARM. THEREFORE THIS MALFUNCTION IS REPORTABLE. THIS COMPLAINT IS NUMBER 13 OF 19 COMPLAINTS REGARDING THE MATTRESSES AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196227 EVOLVE IKY ARJOHUNTLEIGH, INC. PIQ-EV-DPNB3584-N

    Patients

    Seq Age Sex Outcome Treatment
    1