BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 9000

    MDR report key: 3234036 · Received July 11, 2013

    Report

    Report Number
    1419652-2013-00165
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ARJO, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE SOLD MANY BEDS TO THE COMPANY (B)(6), WHICH SOLD THESE BEDS TO HOSPITALS IN (B)(6). OUR CUSTOMER INFORMED US THAT MECHANICAL CPR FOR BACKREST HAS NOT WORKED WHEN A NURSE USED IT. NO CONSEQUENCE FOR PT. CPR CABLE HAS BEEN CHANGED. REF #3007420694-2013-00034.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320705 ENTERPRISE 9000 FNL ARJO, INC. ENT9000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other