BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS MONITOR

    MDR report key: 2477736 · Received February 29, 2012

    Report

    Report Number
    3023750-2012-00011
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K022084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 THEIR ATLAS MONITOR TURNS ON FOR A COUPLE OF SECONDS AND SHUTS OFF. THE CUSTOMER DESCRIBES THAT INTERMITTENTLY, THE DEVICE WILL SOMETIMES SHUT DOWN WHEN THEY ATTEMPT TO TAKE A NIBP READING OR WHEN THEY ATTEMPT TO PRINT. THE UNEXPECTED SHUTDOWN OF A BEDSIDE MONITOR MAY IMPACT THE CLINICIAN'S ABILITY TO HEAR AND SEE CHANGES IN THE PT'S CONDITION. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE AN PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS MONITOR DQA WELCH ALLYN PROTOCOL, INC. 621NP-E1-EX

    Patients

    Seq Age Sex Outcome Treatment
    1