BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 7410291 · Received April 9, 2018

    Report

    Report Number
    2031642-2018-00778
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Report Date
    March 19, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT: 09/21/2018. DATE OF MANUFACTURER: 06/13/2018. DURING FURTHER INVESTIGATION (FI), A VISUAL INSPECTION OF THE USER INTERFACE ASSEMBLY REVEALED NO SIGNS OF DAMAGE OR CONTAMINATION. THE CUSTOMER RETURNED GUI WAS ATTACHED TO THE FI TEST VENTILATOR. THE TEST VENTILATOR WAS CYCLED ON AND OFF 15 TIMES WITHOUT PRODUCING ANY FAILURES. THE CUSTOMER RETURNED GUI ASSEMBLY WAS DISASSEMBLED AND AN INTERNAL VISUAL INSPECTION WAS PERFORMED. THE INTERNAL VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE OR CONTAMINATION, ALL WIRING, CABLE HARNESSES, AND CONNECTORS WERE ROUTED CORRECTLY AND SECURELY. THE CUSTOMER RETURNED USER INTERFACE (GUI) WAS ALLOWED TO RUN FOR APPROXIMATELY FOUR (4) HOURS AND NO ERRORS WERE GENERATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BAD TOUCHSCREEN WAS DETECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249266 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1