BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 AESPIRE 7900

    MDR report key: 6013631 · Received October 10, 2016

    Report

    Report Number
    2112667-2016-01974
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 13, 2016
    Report Date
    October 10, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K050626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASTER WAS REPLACED TO FIX THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, THE WHEEL CASTOR IS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666337 S/5 AESPIRE 7900 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1