BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 1963135 · Received January 18, 2011

    Report

    Report Number
    2031642-2011-00023
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BEING SERVICED BY 3RD PARTY SERVICE COMPANY. (B)(4): POWER SUPPLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP, SHUT DOWN AND ALARMED DURING USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE VENTILATOR WAS SENT TO A 3RD PARTY SERVICE GROUP FOR REPAIR. THE SERVICE TECHNICIAN REPORTED THE DEVICE WOULD NOT POWER ON. THE SERVICE TECHNICIAN WILL REPLACE THE POWER SUPPLY TO ADDRESS THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1