BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITTER

    MDR report key: 2240908 · Received August 8, 2011

    Report

    Report Number
    1523530-2011-00023
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MIDMARK CORP.
    Product Code
    FLE
    PMA / PMN Number
    K990189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY AN INDEPENDENT SERVICE COMPANY AND FOUND TO BE WORKING AS INTENDED. THE REPORTED PROBLEM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    USER WAS LAYING HER ARM ACROSS THE CHAMBER WHILE UNLOADING AND RECEIVED A SHOCK. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITTER STEAM STERILIZER FLE MIDMARK CORP. M11-022

    Patients

    Seq Age Sex Outcome Treatment
    1