BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEMETRY RECEIVER MODULE

    MDR report key: 1162274 · Received September 5, 2008

    Report

    Report Number
    3023361-2008-00051
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN OF THE UNIT TO SPACELABS, AND OUR TESTING OF THE UNIT, SPACELABS FOUND THAT THE UNIT OPERATED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE HOSPITAL STATES THAT A 90478 MODULE FAILED TO ALARM DURING THE HOSPITAL'S TESTING OF THE MODULE, AS INSTRUCTED BY SPACELABS IN ITS 90478 TELEMETRY PRODUCT ALARM FAILURE CORRECTIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEMETRY RECEIVER MODULE NONE DSI SPACELABS HEALTHCARE 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 Other