BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 967280 · Received December 18, 2007

    Report

    Report Number
    1220063-2007-00046
    Event Type
    Malfunction
    Date Received
    December 18, 2007
    Date of Event
    November 7, 2007
    Report Date
    December 18, 2007
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT DURING PATIENT MONITORING SESSION, THE PATIENT MADE AN ASYSTOLIE AND THE MONITOR DIDN'T ALARM ACCORDING TO THE STATEMENTS OF THE CUSTOMER. THE NURSE DIDN'T KNOW IF SHE SAW A RED ALARM ON THE DELTA MONITORS DISPLAY SCREEN, BECAUSE SHE WASN'T DIRECTLY AT THE BEDSIDE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA BEDSIDE PATIENT MONIOTR MHX DRAGER MEDICAL SYSTEMS, INC. (IT/M) MS13477

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR