BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE R860

    MDR report key: 11783017 · Received May 6, 2021

    Report

    Report Number
    2112667-2021-01188
    Event Type
    Death
    Date Received
    May 6, 2021
    Date of Event
    April 5, 2021
    Report Date
    October 7, 2021
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K142679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. THE CUSTOMER ALLEGED THAT THE FILTER ON THE INSPIRATION SAFETY GUARD (ISG) BROKE DURING A CASE AND THE UNIT SUBSEQUENTLY ALARMED  PATIENT DISCONNECTED¿? AT 13:12 ON (B)(6) 2021. THE RESPIRATORY CARE PRACTITIONER (RCP) WAS CALLED TO THE ROOM DUE TO PATIENT DECOMPENSATING. THE RCP LOOKED AT THE CONNECTION AND STATED THE FILTER HAD BROKEN OFF AND IMMEDIATELY BEGAN HAND RESUSCITATING THE PATIENT. WHILE BAGGING THE PATIENT, A REPLACEMENT INSPIRATORY GUARD FILTER AND VENTILATOR WAS OBTAINED. SINCE THE BROKEN PIECE OF THE FILTER COULD NOT BE REMOVED FROM THE VENTILATOR, THE VENTILATOR WAS REPLACED. REPORTEDLY, THE PATIENT DID NOT RECOVER FROM THE INITIAL DECOMPENSATION AND EXPIRED. THE CUSTOMER DID NOT PROVIDE GEHC WITH THE BROKEN FILTER BUT WAS PROVIDED WITH PICTURES OF THE BROKEN ISG THAT SUGGEST THAT THE ISG WAS BROKEN BY AN EXTERNAL IMPACT. THE RESPONSE TO A CUSTOMER QUESTIONNAIRE INDICATED THAT A BEDSIDE X-RAY WAS BEING COMPLETED AT THE TIME OF THE EVENT AND THAT AN X-RAY TECHNICIAN MAY HAVE BUMPED INTO THE FILTER WITH THE X-RAY EQUIPMENT. BASED ON THE INFORMATION FROM THE COMPLAINT AND THE CUSTOMER QUESTIONNAIRE, THE ROOT CAUSE OF THIS INVESTIGATION IS A BROKEN ISG DUE TO POSSIBLE EXTERNAL IMPACT. THE CARESCAPE R860 VENTILATOR PERFORMED AS INTENDED, ALARMING APPROPRIATELY, AND THE COMPLAINT INDICATED AFTER THE EVENT THE SYSTEM WAS DEEMED FULLY FUNCTIONAL FOLLOWING INSPECTION OF THE VENTILATOR.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO PATIENT INFORMATION PROVIDED TO DATE. UNIQUE IDENTIFIER: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL ALLEGED THAT DURING PATIENT USE, THE INSPIRATORY SAFETY GUARD CRACKED AND CAME OFF THE DEVICE LEAVING A PIECE IN THE DEVICE THAT WAS UNABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683609 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC. 1506-8600-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death