BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS HEALTHCARE TELEMETRY RECEIVER

    MDR report key: 5530697 · Received March 28, 2016

    Report

    Report Number
    3010157426-2016-00024
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 6, 2016
    Report Date
    September 25, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE HAS BEEN TRACED TO THE (B)(4) 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. THE PRESENCE OF EXCESSIVE ¿SQUELCH¿ REFLECTS A LOSS OF LARGE NUMBERS OF DATA PACKETS CAUSED BY CLOCK TIMING ERRORS WITHIN THE XTR DEVICE. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER MEDICAL DEVICE EVALUATION RESULTS CODE. THE PREVIOUS CODE WAS (B)(4).

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT ALL CHANNELS OUTPUT FROM THE MODEL 96280 TELEMETRY RECEIVER DISPLAYED A SQUELCH PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186434 SPACELABS HEALTHCARE TELEMETRY RECEIVER XTR MHX SPACELABS HEALTHCARE INC. 96280

    Patients

    Seq Age Sex Outcome Treatment
    1