BEUDAMED
    FDA Adverse Event Other Summary report: N

    SC 6002

    MDR report key: 565336 · Received January 7, 2005

    Report

    Report Number
    1220063-2004-00022
    Event Type
    Other
    Date Received
    January 7, 2005
    Date of Event
    November 16, 2004
    Report Date
    November 22, 2004
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING 161 OF THE SC 6002 PT MONITORS INSTALLED. THEY REPORTED EXPERIENCING HANDLE BREAKAGE ON MULTIPLE MONITORS WHEN THEY TRY TO LIFT THE MONITOR. IT WAS FURTHER STATED THAT IT APPEARS AS THOUGH THE HANDLE MATERAL HAS BECOME FRAGILE, OVER TIME. IT MAKES A POTENTIAL RISK AS LONG AS THE HANDLE BREAKS WHEN THEY TRY TO DOCK THE MONITOR IN THE DOCKING STATION ABOUVE THE HEAD OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SC 6002 PORTABLE PT MONITOR DRT DRAEGER MEDICAL SYSTEMS, INC. 5585570E533U NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA