BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS HEALTHCARE TELEMETRY RECEIVER

    MDR report key: 6372567 · Received March 2, 2017

    Report

    Report Number
    3010157426-2017-00020
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    February 2, 2017
    Report Date
    July 14, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K141156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS TECHNICAL SUPPORT AND THE FIELD SERVICE ENGINEER IMMEDIATELY ASSISTED TO DISCHARGE AND READMIT THE TELEMETRY PATIENTS TO THE DEVICE TO RESUME MONITORING. INVESTIGATION FINDINGS SHOW THAT THE CAUSE WAS DUE TO A QUAD RECEIVER CARD (QRC) PROBLEM. REPLACING THE QRC RESOLVED THE PROBLEM. THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS AND WAS RESTORED TO SERVICE. THIS REPORT IS COMPLETE AND THIS PARTICULAR ISSUE IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2017, A LOSS OF TELEMETRY MONITORING OCCURRED AT THE CENTRAL MONITOR. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154213 SPACELABS HEALTHCARE TELEMETRY RECEIVER XTR MHX SPACELABS HEALTHCARE INC. 96280

    Patients

    Seq Age Sex Outcome Treatment
    1