BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (INCL M540)

    MDR report key: 3881250 · Received February 13, 2014

    Report

    Report Number
    9611500-2014-00022
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 7, 2014
    Report Date
    February 13, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    MHX
    PMA / PMN Number
    K092788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE MONITOR WILL NOT EXECUTE A LOW SPO2 ALARM UNDER THE FOLLOWING SPECIAL CONDITIONS: IF THE USER ADJUSTS THE SPO2 ALARM LIMITS DURING AN ACTIVE MEDIUM-GRADE LIMIT VIOLATION ALARM AND WITH A CERTAIN FEATURE ENABLED, ALL SPO2 LIMIT VIOLATION ALARMS WILL BE SUSPENDED UNTIL THE SPO2 VALUE RETURNS TO A VALUE INSIDE THE BOUNDARIES SET FORTH BY THE NEW SPO2 ALARM LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95257 INFINITY ACUTE CARE SYSTEM (INCL M540) PATIENT MONITOR MHX DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1