BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESCAPE R860

    MDR report key: 18978660 · Received March 26, 2024

    Report

    Report Number
    2112667-2024-01625
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    February 1, 2024
    Report Date
    June 13, 2024
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    UDI-DI
    00840682102346
    PMA / PMN Number
    K210384
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S (GEHC) INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE IS A LEAK IN THE PATIENT BREATHING CIRCUIT CAUSED BY THE PATIENT PULLING AT THE MASK. THERE WAS NO MALFUNCTION OF THE GEHC DEVICE.

    Additional Manufacturer Narrative · 0

    GEHS INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO PATIENT INFORMATION HAS BEEN PROVIDED. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT WAS CONNECTED TO A CARESCAPE R860 VENTILATOR WHEN IT WAS ALLEGED THAT THE DEVICE STOPPED CYCLING AND DELIVERING FLOW TO THE PATIENT WHILE THE PATIENT WAS UNDER NON-INVASIVE (NIV) VENTILATION WITH A MASK. THE DISPLAY THEN STOPPED PRESENTING PATIENT INFORMATION AND SHOWED APNEA ALARMS. REPORTEDLY, THE PATIENT DESATURATED TO 55% FOR 5 MINUTES. THE PATIENT INTUBATED, AND THE UNIT WAS REPLACED DURING THE CASE. THERE WAS NO PATIENT SEQUELAE REPORTED. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13388 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC. 1506-8600-000AP-AV 00840682102346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown