BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS MONITOR

    MDR report key: 2434568 · Received January 26, 2012

    Report

    Report Number
    3023750-2012-00007
    Event Type
    Death
    Date Received
    January 26, 2012
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    WELCH 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

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THEY HAVE AN ATLAS MONITOR THAT LOST POWER FOR UNK REASON. THE CUSTOMER INDICATED THAT THIS OCCURRED WITHOUT ANY AUDIBLE OR VISUAL ALARMS. 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. NOTE 1 FOR BLOCK A: THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS MONITOR DQA WELCH ALLYN PROTOCOL, INC. 623NP-G2

    Patients

    Seq Age Sex Outcome Treatment
    1