BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODEL 90478 TELEMETRY RECEIVER MODULE

    MDR report key: 1061135 · Received June 13, 2008

    Report

    Report Number
    3023361-2008-00014
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    April 21, 2005
    Report Date
    June 13, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K925510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION DETERMINED THAT IN CERTAIN RARE CIRCUMSTANCES OUR ECG SOFTWARE FAILS TO DETECT AN ASYSTOLE EVENT AND ALARM FOR IT. FOR THIS CONDITION TO EXIST, THE PATIENT MUST EXHIBIT LARGE P WAVES (25% OF QRS) WITH NO QRS. IN THIS SITUATION, A LOW RATE ALARM WOULD STILL BE GENERATED. THERE HAVE BEEN NO PATIENT INJURIES OR DEATHS REPORTED IN ASSOCIATION WITH THIS CONDITION. THIS IS THE FIRST REPORTED INCIDENT OF THIS TYPE DESPITE THE FACT THAT SPACELABS HAS OVER 100,000 ECG MODULES IN THE FIELD, MANY OF THEM IN USE FOR OVER 20 YEARS. EVEN THOUGH THIS CONDITION IS RARE, SPACELABS HAS MODIFIED THE BEAT DETECTION LOGIC IN OUR SOFTWARE ASSOCIATED WITH THIS CONDITION TO BETTER DETECT AN ASYSTOLE EVENT, AS A PRODUCT IMPROVEMENT.

    Description of Event or Problem · 1

    BIOMEDICAL ENGINEER REPORTED AN INCIDENT WHERE SPACELABS TELEMETRY EQUIPMENT DID NOT GENERATE AN ASYSTOLE ALARM IN RESPONSE TO A PAUSE EVENT. A NURSE WITH THE PATIENT NOTICED THE PATIENT'S SYMPTOMS AND STARTED RESUSITATION. AT THAT TIME, THE NURSE NOTICED THAT THE MONITOR HAD NOT GENERATED AN ASYSTOLE ALARM DURING AN 11 SECOND PAUSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention