BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARESCAPE CENTRAL STATION V2

    MDR report key: 8374710 · Received February 27, 2019

    Report

    Report Number
    3008729547-2019-00001
    Event Type
    Death
    Date Received
    February 27, 2019
    Date of Event
    January 30, 2019
    Report Date
    April 17, 2019
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    DXJ
    PMA / PMN Number
    K162012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS: THIS CENTRAL STATION (CARESCAPE CENTRAL STATION V2) WAS INSTALLED IN (B)(6) 2018. THE CUSTOMER WAS PROVIDED WITH GE APPROVED KEYBOARDS AT THAT TIME; THE CUSTOMER HAD PURCHASED WIRELESS KEYBOARDS AND OPTED TO USE. SHORTLY AFTER INSTALL THEY EXPERIENCED NO AUDIBLE SOUND AT A CENTRAL STATION AND FOUND STAFF HAD USED THE MUTE BUTTON ON THE CUSTOMER PURCHASED WIRELESS KEYBOARD. THE CUSTOMER WAS INFORMED THAT THEIR KEYBOARD WAS NOT APPROVED FOR USE. THE CUSTOMER REPORTED THAT ON (B)(6) 2019, A PATIENT IN BED ED/41 EXPIRED AND THERE WERE NO AUDIBLE ALARMS AT THE CENTRAL STATION. DEVICE EVALUATION FOUND THE CUSTOMERS WIRELESS KEYBOARD WAS MISSING; A BIOMEDICAL TECHNICIAN AT THE SITE TESTED THE SYSTEM AND CONFIRMED THERE WAS NO AUDIO. WHEN THE CUSTOMERS WIRELESS KEYBOARD WAS CONNECTED PRESSING THE MUTE BUTTON RESTORED AUDIO FUNCTION. LOG FILES FROM BOTH THE CENTRAL STATION AND BEDSIDE MONITOR TO WHICH THE PATIENT WAS CONNECTED WERE COLLECTED AND REVIEWED. BOTH DEVICE LOG FILES INDICATE THAT ALARMS WERE PROVIDED DURING THE EVENT IN QUESTION. THE INVESTIGATION DETERMINED THAT CUSTOMER USE OF THE MUTE BUTTON ON AN UNAPPROVED WIRELESS USB KEYBOARD CAUSED THE CENTRAL STATION AUDIBLE ALARMS TO BE TURNED OFF WITHOUT USER KNOWLEDGE. THE CUSTOMER CONTINUED TO USE UNAPPROVED WIRELESS KEYBOARDS AFTER BEING INFORMED BY THE MANUFACTURER NOT TO DO SO. THE CENTRAL STATION OPERATOR'S MANUAL ALSO PROVIDES A WARNING RELATED TO USE OF UNAPPROVED ACCESSORIES.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI): (B)(4). GE HEALTHCARE'S INVESTIGATION IS ON-GOING AT THIS TIME; A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE DID NOT PROVIDE AUDIBLE ALARMS AND THE PATIENT WAS FOUND DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166834 CARESCAPE CENTRAL STATION V2 DISPLAY, CATHODE-RAY TUBE, MEDICAL DXJ CRITIKON DE MEXICO S. DE R.L. DE C.V. 2092670-001

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death