BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSCA 500 USA

    MDR report key: 5067272 · Received September 8, 2015

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    3002807968-2015-00021
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 5, 2015
    Report Date
    March 9, 2017
    Product Code
    DPZ
    PMA / PMN Number
    K063434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR TEMPERATURE WAS NOTED AT 44 DEGREES CELSIUS. THE USER MANUAL FOR THE TOSCA 500 STATES A RECOMMENDED TEMPERATURE OF 42 DEGREES CELSIUS AND A MAXIMUM TEMPERATURE OF 44 DEGREES CELSIUS. THE CUSTOMER EXPLAINED THAT THIS MONITOR WAS USED FOR SLEEP STUDIES THAT CAN LAST UP TO 10 HOURS, AND THAT THE SITE TIME WAS SET AT 9 HOURS. HOWEVER, THE USER MANUAL FOR TOSCA 500 INSTRUCTS A MAXIMUM SITE TIME OF 4 HOURS WHEN SETTING THE TEMPERATURE AT 44 DEGREES CELSIUS. THE PROLONGED SITE TIME AT THE HIGH TEMPERATURE INDICATES THAT THE EVENT WAS CAUSED BY A USER ERROR.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT ADVERSE EVENT WAS CHECKED BUT IT WAS NOT AN ADVERSE EVENT BUT A MALFUNCTION DUE TO A USE ERROR WHY NO MDR SHOULD HAVE BEEN FILED. SERIOUS INJURY SHOULD HAVE BEEN LEFT BLANK IN INITIAL REPORT. INITIAL REPORT: THE COVER LETTER STATES "...FOR A SERIOUS INJURY INVOLVING CLINITUBES". THE CASE CONCERNS TCM TOSCA 500 SENSOR 92, SO THE CORRECT STATEMENT IS "...FOR A SERIOUS INJURY INVOLVING TCM TOSCA 500 SENSOR 92".

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593761 TOSCA 500 USA TOSCA 500 USA MONITOR DPZ 5201008

    Patients

    Seq Age Sex Outcome Treatment
    1