BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX-OHMEDA S/5 M-NESTPR MODULE

    MDR report key: 373389 · Received January 22, 2002

    Report

    Report Number
    9610105-2002-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2002
    Report Date
    January 16, 2002
    Manufacturer
    INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DATEX-OHMEDA SPO2 MEASUREMENT DISPLAYED 98% WITH A SAT OF 65%! IT KEPT READING EVEN WHEN TAKEN OFF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 M-NESTPR MODULE DATEX-OHMEDA MULTIPARAMETER PATIENT MONITOR MHX INSTRUMENTARIUM CORP./DATEX-OHMEDA DIVISION M-NESTPR *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other