BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYRAMIS

    MDR report key: 4799418 · Received May 22, 2015

    Report

    Report Number
    2183461-2015-00001
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 1, 2015
    Report Date
    May 22, 2015
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DQK
    PMA / PMN Number
    K032038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PYRAMIS SN (B)(4) IS A SOFTWARE PRODUCT THAT DOES NOT NEED TO BE RETURNED TO MORTARA TO PERFORM AN EVAL. MORTARA IS PERFORMING AN ENGINEERING EVAL OF THE SOFTWARE RELATED TO THIS CUSTOMER COMPLAINT. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON THREE OCCASIONS WHEN ECGS WERE CAPTURED ON THE ELI380 ELECTROCARDIOGRAPH AND TRANSMITTED TO PYRAMIS, THE PT DEMOGRAPHIC INFO DID NOT MATCH THE ORDER NUMBER. WITH EACH OCCURRENCE THE TECH FOUND THE MISMATCH, EDITED THE PT DEMOGRAPHIC INFO, AND SAVED THE RECORD. THERE HAVE BEEN NO PT INJURIES OR MISDIAGNOSES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337506 PYRAMIS PYRAMIS DQK MORTARA INSTRUMENT, INC. 92601Z-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA