BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS MONITOR

    MDR report key: 3040411 · Received March 12, 2013

    Report

    Report Number
    3023750-2013-00036
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    WLECH ALLYN PROTOCOL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K022084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY HAVE AN ATLAS MONITOR THAT POWERED DOWN WHILE IN USE. THE UNEXPECTED SHUTDOWN OF A BEDSIDE MONITOR MAY IMPACT CLINICIAN'S ABILITY TO HEAR AND SEE CHANGES IN THE PT'S CONDITION. THERE WAS NO PT HARM AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104287 ATLAS MONITOR DQA WLECH ALLYN PROTOCOL, INC. 623NP-E1

    Patients

    Seq Age Sex Outcome Treatment
    1