BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS TELEMETRY RECIEVER HOUSING

    MDR report key: 6059374 · Received October 26, 2016

    Report

    Report Number
    3010157426-2016-00159
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    PMA / PMN Number
    K983996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PROBLEM WAS VERIFIED IN SPACELABS SERVICE REPAIR. THE POWER SUPPLY BOARD, BATTERY, AND SWITCH WERE REPLACED. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RESTORED TO SERVICE. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(6) 2016 THE TELEMETRY MODULE HOUSING HAD FAILED TO POPULATE ZONES ON THE CENTRAL MONITOR DURING PATIENT USE. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710266 SPACELABS TELEMETRY RECIEVER HOUSING TELEMETRY HOUSING DSI SPACELABS HEALTHCARE INC. 90479

    Patients

    Seq Age Sex Outcome Treatment
    1