BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRESS TEST

    MDR report key: 7910525 · Received September 25, 2018

    Report

    Report Number
    MW5080136
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 23, 2018
    Report Date
    September 24, 2018
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARDIOVASCULAR TECHNICIAN WAS PERFORMING A GRADED EXERCISE TEST ON THE PATIENT. WHEN IT WAS TIME TO PLACE THE PATIENT IN A RECOVERY STATUS, (B)(6) STATED THAT THE STRESS CART FROZE UP AND EXITED THE TEST. SHE UNABLE TO RETRIEVE ANYMORE INFORMATION OF CAPTURE REMAINING ECG¿S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746777 STRESS TEST ELECTROCARDIOGRAPH - X - SCRIBE II STRESS TESTING SYSTEM DPS MORTARA INSTRUMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1