BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 6037019 · Received October 18, 2016

    Report

    Report Number
    3010157426-2016-00154
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 24, 2016
    Report Date
    October 18, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) 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 TWO TELEMETRY BEDS WENT OFFLINE FROM THE XHIBIT CENTRAL MONITOR. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687759 SPACELABS XHIBIT CENTRAL STATION S-CLASS CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1 96280