BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS ULTRAVIEW SL COMMAND MODULE

    MDR report key: 3081348 · Received April 26, 2013

    Report

    Report Number
    3023361-2013-00030
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K050605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ONE WAS INJURED AS A RESULT OF THIS EVENT. THE MODULE WAS SENT IN TO SPACELABS EQUIPMENT SERVICE CENTER FOR A SERVICE REPAIR. NO ECG STRIPS WERE PROVIDED AND ARE NOT AVAILABLE, THERE WERE NO DETAILS PROVIDED BY THE HOSPITAL REGARDING THE ALARM TYPE REPORTED. THE REPORTED PROBLEM COULD NOT BE DUPLICATED AND THE MODULE HAS BEEN FUNCTIONALLY TESTED AND FOUND TO BE OPERATING TO SPECIFICATIONS. THE DEVICE HAS BEEN RETURNED TO THE CUSTOMER. THERE HAVE BEEN NO FURTHER REPORTS CONCERNING THIS DEVICE. SPACELABS CONSIDERS THIS ISSUE CLOSED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    NO ONE WAS INJURED AS A RESULT OF THIS EVENT. SPACELABS IS EVALUATING THIS EVENT AND WILL FILE A FOLLOW UP REPORT WHEN OUR EVALUATION IS CONCLUDED. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT NO ALARM WAS GENERATED IN THE MODULE.

    Description of Event or Problem · 1

    NO ALARM WAS GENERATED IN MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181046 SPACELABS ULTRAVIEW SL COMMAND MODULE ULTRAVIEW MULTIPARAMETER MODULE DSI SPACELABS MEDICAL INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 91496 (1496-109245)