BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESCAPE R860

    MDR report key: 9583021 · Received January 13, 2020

    Report

    Report Number
    2112667-2020-00119
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    September 26, 2019
    Report Date
    January 13, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K142679
    Removal / Correction Number
    SEEH10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 17 OCTOBER 2018. THE FDA RECALL NUMBER IS Z-0463-2019. THE ISSUE OF THE INSPIRATORY SAFETY GUARD (ISG)IS BEING ADDRESSED THROUGH THE GE HEALTHCARE (GEHC) REPORTED FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 17 OCTOBER 2018. THE FDA RECALL NUMBER IS Z-0463-2019. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE WHICH INCLUDED PHOTOS OF THE ISSUE AND THE FOLLOWING SAFETY INSTRUCTIONS WERE PROVIDED: SAFETY INSTRUCTIONS #1: YOU MAY CONTINUE TO USE YOUR VENTILATOR WITH THE ISG OUTLET IF THE 15MM FEMALE CONICAL CONNECTOR IS INSPECTED FOR A SECURE FIT IN THE LOCATION INDICATED BELOW WHERE ENGAGEMENT RESISTANCE WOULD NORMALLY OCCUR (SEE FIGURE 1 "CORRECT INSPIRATORY SAFETY GUARD (ISG)"). NOTE: AN ISG CURRENTLY IN USE WITH ADULT OR PEDIATRIC PATIENTS UTILIZING 22MM MALE CIRCUIT CONNECTION ARE NOT ASSOCIATED WITH THIS ISSUE AND ARE SAFE FOR CONTINUED USE AFTER INSPECTION OF BOTH INLET AND OUTLET ISSUES HAVE BEEN COMPLETED. WHEN SYSTEMS ARE NO LONGER IN USE, INSPECT FOR 15MM INCORRECT CONNECTION PER THE INSTRUCTION IN FIGURE 1.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A DEFECTIVE VENTILATOR INSPIRATORY SAFETY GUARD (ISG) RESULTING IN A LOSS OF VENTILATION WHICH MAY LEAD TO INADEQUATE OXYGENATION FOR PATIENTS, INCREASING THE POSSIBILITY OF HYPOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46472 CARESCAPE R860 VENTILATOR, CONTINUOUS, FACILITY USE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1