BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS

    MDR report key: 6208583 · Received December 28, 2016

    Report

    Report Number
    2112667-2016-02540
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 28, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL WILL REPLACE THE BATTERIES.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, THE UNIT ALARMED FOR DEPLETED BATTERY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858127 AISYS ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1