BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE R860

    MDR report key: 15318954 · Received August 30, 2022

    Report

    Report Number
    2112667-2022-03169
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 1, 2022
    Report Date
    September 13, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K142679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. UNIQUE IDENTIFIER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR 2112667-2022-03169 #1 IS BEING FILED AS A CORRECTION TO REPORT THAT THE INITIAL MDR WAS A DUPLICATE OF INITIAL MDR 2112667-2022-03151. H3 OTHER TEXT : THIS SUPPLEMENTAL MDR 2112667-2022-03169 #1 IS BEING FILED AS A CORRECTION TO REPORT THAT THE INITIAL MDR WAS A DUPLICATE OF INITIAL MDR 2112667-2022-03151.

    Description of Event or Problem · 0

    DURING DEVICE TESTING, A BATTERY FAILURE, WHICH COULD RESULT IN A LOSS OF MECHANICAL VENTILATION, WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300708 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown