BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 2600323 · Received June 6, 2012

    Report

    Report Number
    3023361-2012-00026
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    May 10, 2012
    Report Date
    August 13, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DXG
    PMA / PMN Number
    K103142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS TESTED BY SPACELABS AT BOTH THE HOSPITAL AND AT THE SPACELABS FACILITY WITH NO PROBLEM FOUND. THE CUSTOMER PROVIDED 6 PATIENT WAVEFORM STRIPS WITH ALLEGED ALARM FAILURES. THE EVALUATION OF THE STRIPS CONFIRMED THAT THE DEVICE WORKED TO SPECIFICATIONS. A REVIEW OF THE PATIENT'S FULL DISCLOSURE DATA INDICATED THAT THE MONITOR DID ALARM ON PAROXYSMAL SUPRA-VENTRICULAR TACHYCARDIA (PSVT) FROM 4 STRIPS AND ALARM ON A VENTRICULAR RUN FROM 1 STRIP. THERE IS 1 STRIP WITH NO ALARM BECAUSE THE PATIENT HAD AN ELEVATED HEART RATE FOR 2 MINUTES PRIOR TO THE ARRHYTHMIA, WHICH PREVENTED IT FROM BEING QUALIFIED AS A RUN ALARM. THE CUSTOMER HAS BEEN MADE AWARE OF OUR FINDINGS AND WE HAVE CONCLUDED THAT THIS REPORT IS FINAL AND CONSIDER THIS ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE MATTER AT THE CUSTOMER'S SITE AND CONFIRMED THE ISSUE. WE HAVE REPLACED THE AFFECTED MODULE ON THE CUSTOMER'S SITE AND ARE COLLECTING MORE DATA AND INFORMATION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR FAILED TO ALARM ON PAROXYSMAL SUPRA-VENTRICULAR TACHYCARDIA (PSVT).

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT MONITOR FAILED TO ALARM ON PAROXYSMAL SUPRA-VENTRICULAR TACHYCARDIA (PSVT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DXG SPACELABS MEDICAL INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR MODEL 91387 PATIENT MONITOR, SN: (B)(4)| MODEL 91387 PATIENT MONITOR, SN: (B)(4)