BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS HEALTHCARE TELEMETRY RECEIVER

    MDR report key: 5345737 · Received January 5, 2016

    Report

    Report Number
    3010157426-2016-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 10, 2015
    Report Date
    April 21, 2016
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K141156
    Removal / Correction Number
    RES73634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ISSUE HAS BEEN TRACED TO THE TEXAS INSTRUMENT (TI) MSP430. MICROCONTROLLER USED ON THE MODEL 96280 TELEMETRY RECEIVER QUAD RECEIVER CARD (QRC) PCBA THAT HAS AN INTERNAL HARDWARE DEFECT THAT AFFECTS THE PROPER CLOCKING OF DIGITAL DATA COMMUNICATIONS ON SOME QRC UNITS. IN ORDER TO CORRECT THIS ISSUE, A NEW VERSION OF THE TI MSP430 IS BEING IMPLEMENTED THAT INCLUDES A HARDWARE CORRECTION FOR THE CLOCKING DEFECT. SPACELABS CONSIDERS THIS MEDWATCH CLOSED. FURTHER ACTIONS AND INFORMATION WILL BE DOCUMENTED UNDER THE SPACELABS FIELD CORRECTIVE ACTION PROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, SPACELABS RECEIVED A REPORT THAT TELEMETRY XHIBIT CENTRAL WAS HAVING FORMAT AND DISPLAY ISSUES WHICH RESULTED IN THE LOSS OF PATIENT DATA DISPLAY. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3394 SPACELABS HEALTHCARE TELEMETRY RECEIVER XTR MHX SPACELABS HEALTHCARE INC. 96280

    Patients

    Seq Age Sex Outcome Treatment
    1