BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN TOUCH ZU

    MDR report key: 2130686 · Received June 13, 2011

    Report

    Report Number
    1831750-2011-05874
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE INTOUCH BED IS SET AT "MAX INFLATE" WITH AN INTEGRATED XPERT MATTRESS THAT IT DOES NOT TIME OUT. THERE WERE THREE INSTANCES OF REPORTED PATIENT INVOLVEMENT AND AN ALLEGED ADVERSE EVENT OF ACQUIRED PRESSURE SORES, HOWEVER, IT IS UNKNOWN WHICH UNITS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN TOUCH ZU A/C HOSPITAL BED FNL STRYKER MEDICAL 2141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK