BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTATION 650

    MDR report key: 11207797 · Received January 21, 2021

    Report

    Report Number
    2112667-2021-00200
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 24, 2020
    Report Date
    January 21, 2021
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K151570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER: (B)(4). GE HEALTHCARE REVIEW OF THE LOG CONFIRMED ERROR. THE CUSTOMER DECLINED GE SERVICE. NO REPAIR INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A DRIVE GAS ERROR PREVENTING MECHANICAL VENTILATION. THE UNIT WAS REPLACED AND CASE RESUME. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108246 CARESTATION 650 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1012-9650-000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR