BEUDAMED
    FDA Adverse Event Death Summary report: N

    MR880 TRACHE DIRECT CONNECTION

    MDR report key: 1939923 · Received December 28, 2010

    Report

    Report Number
    9611451-2010-00780
    Event Type
    Death
    Date Received
    December 28, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FISHER & PAYKEL HEALTHCARE HAS MET WITH THE HOSPITAL TO OBTAIN ADDITIONAL INFORMATION AND IS CURRENTLY CARRYING OUT AN INVESTIGATION OF THE REPORTED INCIDENT. WE WILL PROVIDE A FOLLOW-UP REPORT OUTLINING OUR ANALYSIS OF THE INCIDENT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT INTERFACE WAS NOT AVAILABLE FOR EVALUATION. FISHER & PAYKEL HEALTHCARE'S INVESTIGATION WAS CARRIED OUT BASED ON INFORMATION PROVIDED BY THE HOSPITAL. FISHER & PAYKEL HEALTHCARE (B)(4) PRODUCT DEVELOPMENT MANAGER VISITED THE HOSPITAL TWICE REGARDING THE REPORTED INCIDENT. THE HOSPITAL HAS ADVISED FISHER & PAYKEL HEALTHCARE THAT IT DOES NOT CONSIDER THAT THE REPORTED DEATH WAS CAUSED BY A FAILURE OR DEFECT OF THE INTERFACE. IN RESPONSE TO THE REPORTED INCIDENT, EVERY RESPIRATORY STAFF MEMBER AT THE HOSPITAL HAS BEEN RE-EDUCATED REGARDING THE POLICIES AND PROCEDURES REGARDING THE CARE OF PATIENTS WHO ARE ON SETUPS WHICH INCLUDE THE FISHER & PAYKEL HEALTHCARE OPT SERIES INTERFACES, INCLUDING THE OPT570 TRACHEOSTOMY INTERFACE. THE STAFF IN THE RESPIRATORY THERAPY WARD OF THE HOSPITAL HAVE ALSO INSTITUTED A PROCEDURE REGARDING THE SECURE CONNECTION OF THE OPTIFLOW TRACHEOSTOMY ADAPTORS. FISHER & PAYKEL HEALTHCARE HAS RECEIVED NO OTHER COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A PATIENT, WHO WAS ON A SETUP WHICH INCLUDED AN OPT570 TRACHEOSTOMY INTERFACE FOR ABOUT 2-3 HOURS, WAS FOUND TO BE DISCONNECTED FROM THE TRACHEOSTOMY TUBE. IT WAS REPORTED THAT THE PATIENT WAS NOT BREATHING AND WAS CYANOTIC WHEN THE DISCONNECTION WAS DISCOVERED BY HOSPITAL STAFF. THE PATIENT WAS PRONOUNCED DEAD SHORTLY AFTER. THE HOSPITAL REPORTED THAT THEY WERE UNSURE WHETHER THE OPT570 INTERFACE HAD BEEN PULLED OFF BY THE PATIENT OR WHETHER IT HAD FALLEN OFF.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A PATIENT, WHO WAS ON A SETUP WHICH INCLUDED AN OPT570 TRACHEOSTOMY INTERFACE ("INTERFACE") FOR ABOUT 2-3 HOURS, WAS FOUND TO BE DISCONNECTED FROM THE TRACHEOSTOMY TUBE. IT WAS REPORTED THAT THE PATIENT WAS NOT BREATHING AND WAS CYANOTIC WHEN THE DISCONNECTION WAS DISCOVERED BY HOSPITAL STAFF. THE PATIENT WAS PRONOUNCED DEAD SHORTLY AFTER. THE HOSPITAL REPORTED THAT THEY WERE UNSURE WHETHER THE INTERFACE HAD BEEN PULLED OFF BY THE PATIENT OR WHETHER IT HAD FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR880 TRACHE DIRECT CONNECTION BZA BZA FISHER & PAYKEL HEALTHCARE LIMITED OPT570 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death PACEMAKER| PACEMAKER