BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 90478 TELEMETRY RECEIVER MODULE

    MDR report key: 1172551 · Received September 20, 2008

    Report

    Report Number
    3023361-2008-00056
    Event Type
    Malfunction
    Date Received
    September 20, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 22, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K925510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP PROVIDED A PRINTOUT OF ONLY ONE PT LEAD. BASED ON THIS INFO ALONE WE WOULD CONCLUDE THAT THE 5.4 SECOND PAUSE SHOULD HAVE ALARMED AS AN ASYSTOLE EVENT. HOWEVER, WITHOUT A COMPLETE STRIP OF ALL OF THE ECG LEADS AT THE TIME OF THE INCIDENT, WE CANNOT FORECLOSE THE POSSIBILITY OF ACTIVITY ON ANOTHER LEAD THAT COULD HAVE PREVENTED A PAUSE READING. FOR THESE REASONS, WE CANNOT CONCLUSIVELY DETERMINE WHAT CAUSED THE PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A SPACELABS CENTRAL STATION IN USE WITH A MODULE DID NOT ALARM FOR AN ASYSTOLE CONDITION AFTER A 5.4 SECOND PAUSE IN THE PT'S HEARTBEAT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1