BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSIOMONITORYING SYSTEM, INFO

    MDR report key: 8063663 · Received November 13, 2018

    Report

    Report Number
    1051786-2018-00020
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Report Date
    March 29, 2018
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ECG IS DROPPING QRS COMPLEXES. ACCORDING TO THE CUSTOMER, THE RIGHT SCREEN (LIVE) WILL NOT DROP THE QRS FROM THE EKG, BUT IT FREQUENTLY WILL HAVE AN ELONGATED QRS. THE LEFT SCREEN (SWITCH) WILL HAVE DROPPED QRS¿S FREQUENTLY. FURTHER STATING, THAT IT OCCURS ESPECIALLY RIGHT AFTER HITTING ¿SWITCH¿, BUT CONTINUES TO DROP VERY FREQUENTLY AS LONG AS THE LEFT SCREEN DISPLAYS THE EKG. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902509 PHYSIOMONITORYING SYSTEM, INFO MWI INVIVO CORPORATION FC2010 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1