BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 6174714 · Received December 15, 2016

    Report

    Report Number
    3010157426-2016-00198
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 14, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE HAS BEEN IDENTIFIED AS A SOFTWARE PROBLEM. SPACELABS HAS INITIATED A FIELD CORRECTIVE ACTION AND NOTIFIED THE FDA (B)(6) OFFICE OF THIS ACTION ON AUGUST 25TH, 2016 (RECALL NUMBER: Z-2885-2016). WE ALSO NOTIFIED CUSTOMERS OF THIS ACTIVITY WITH A LETTER DATED AUGUST 25TH, 2016. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2016 THE XHIBIT CENTRAL MONITOR SYSTEM DISPLAYED AN ¿OFFLINE¿ MESSAGE IN THE PATIENT ZONES FOR ALL TELEMETRY BEDS. THE ISSUE WAS RESOLVED BY HARD RESET. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830254 SPACELABS XHIBIT CENTRAL STATION S-CLASS CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1 96280