BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE R860

    MDR report key: 18746876 · Received February 21, 2024

    Report

    Report Number
    2112667-2024-00945
    Event Type
    Death
    Date Received
    February 21, 2024
    Date of Event
    February 3, 2022
    Report Date
    July 8, 2024
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K210384
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A2, A3, A4, A5, AND A6: NO INFORMATION PROVIDED TO DATE. BLOCK D4 SERIAL NUMBER: NOT PROVIDED. BLOCK G2 REPORT SOURCE OTHER: (B)(6). BLOCK H4 DATE OF DEVICE MANUFACTURE: UNKNOWN AS NO SERIAL NUMBER PROVIDED. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE SERVICE WAS NOT REQUESTED OR DELIVERED. BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THERE WAS NO EVIDENCE OF A RESPIRATOR MALFUNCTION. THE GE HEALTHCARE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS CONNECTED TO A CARESCAPE R860 VENTILATOR WHEN IT WAS ALLEGED THERE WAS AN AIR LEAK FROM THE VENTILATOR TUBE. REPORTEDLY, THE PATIENT SUBSEQUENTLY EXPERIENCED HYPOXIA WHICH NECESSITATED MEDICAL TREATMENT INCLUDING SURGERY. THE PATIENT PASSED AWAY, CAUSE OF DEATH LISTED AS MULTI ORGAN FAILURE. 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
    1415365 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D