BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS MONITOR

    MDR report key: 3002666 · Received February 13, 2013

    Report

    Report Number
    3023750-2013-00022
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K022084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY HAVE AN ATLAS MONITOR THAT INTERMITTENTLY POWERS DOWN WHEN PLUGGED INTO AN ELECTRICAL OUTLET. THE UNEXPECTED SHUTDOWN OF A BEDSIDE MONITOR MAY IMPACT CLINICIAN'S ABILITY TO HEAR AND SEE CHANGES IN THE PATIENT'S CONDITION. THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63796 ATLAS MONITOR DQA WELCH ALLYN PROTOCOL, INC. 623NP-E1R

    Patients

    Seq Age Sex Outcome Treatment
    1