BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11572945 · Received March 25, 2021

    Report

    Report Number
    2031642-2021-03125
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 24, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD AN 'ODD NOISE' DURING USE. THE CUSTOMER'S BIOMEDICAL ENGINEER INSPECTED THE DEVICE AND FOUND AN ERROR CODE INDICATING THE VENTILATOR WAS RESTARTED IN THE VENTILATOR DIAGNOSTIC REPORT DUE TO ANOMALIES DETECTED DURING OPERATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER TROUBLESHOT WITH TECHNICAL SUPPORT. THE CUSTOMER HAD ORDERED A CENTRAL PROCESSING UNIT (CPU). THE CUSTOMER WAS ABLE TO INSTALL THE CPU TO ADDRESS THE REPORTED ISSUE. THE CUSTOMER DISPOSED THE CPU, AND IT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469586 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1