BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPACELABS DIGITAL TELEMETRY TRANSMITTER

    MDR report key: 2462004 · Received February 21, 2012

    Report

    Report Number
    3023361-2012-00004
    Event Type
    Death
    Date Received
    February 21, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 20, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K925510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER (FSE) TESTED THE SUBJECT DEVICE AT THE CUSTOMER'S SITE AND CONFIRMED THE DEVICE WORKED TO SPECIFICATIONS. A REVIEW OF THE WAVEFORM DATA FROM THE (B)(6) DATABASE INDICATED THAT DEVICE DID ALARM BEFORE THE EVENT. THE DATA ALSO INDICATED THAT THE ECG PROCESSING WAS SUSPENDED AT 10:51PM ON (B)(6), 2012 AND WAS NOT REMOVED FROM SUSPEND MODE FOR THAT BED. WHEN ECG PROCESSING IS SUSPENDED, THE ANALYSIS OF THE ECG WAVEFORM INCLUDING ARRHYTHMIA CLASSIFICATION IS SUSPENDED THEREFORE NO ALARM WAS GENERATED DURING THE EVENT. THE ROOT CAUSE WAS IDENTIFIED AS THE USER'S IMPROPER OPERATION. THE SUPEND MODE IS TO ALLOW STAFF TO ELIMINATE NUISANCE ALARMS CAUSED BY PATIENT LEAVING THE FLOOR OR GETTING INTO THE SHOWER. WHEN THE SUSPEND PROCESSING KEY IS HIT, A CONFIRMATION IS REQUIRED FROM THE USER TO SELECT THIS OPTION. AFTER THE OPTION IS CONFIRMED, A MESSAGE ECG PROCESSING SUSPENDED WILL APPEAR IN THE ECG WAVEFORM ZONE. SPACELABS HAS CONFIRMED THAT THE CUSTOMER UNDERSTANDS THE SIGNIFICANCE OF SUSPENDING THE PROCESSING AND SHOWED THE CUSTOMER HOW TO REMOVE SUSPEND MODE FROM THE MONITOR. SPACELABS HAS OFFERED THE CUSTOMER REMEDIAL TRAINING ON PROPER OPERATION AND THIS WAS ACCEPTED BY THE CUSTOMER. THE HOSPITAL IS CONTINUING TO USE THE DEVICE TO MONITOR PATIENTS. THIS REPORT IS CONSIDERED FINAL AND THE ISSUE IS CLOSED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A TELEMETRY MONITOR FAILED TO ALARM WHEN PATIENT WAS IN CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS DIGITAL TELEMETRY TRANSMITTER TELEMETRY TRANSMITTER DSI SPACELABS MEDICAL INC. 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MODEL 91347 AND MODEL 91387