BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 22053450 · Received May 20, 2025

    Report

    Report Number
    2518422-2025-045189
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WAS PERFORMED WITH THE CUSTOMER, AND IT WAS REPORTED THAT THE DEVICE WAS QUARANTINED, AND THAT THE FILTERS WERE REPLACED.

    Additional Manufacturer Narrative · 0

    E1: REPORTING ADDRESS STATE: (B)(6). REPORTING ADDRESS POSTAL: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR WAS USED ON A PATIENT WITHOUT A FILTER. THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER REPORTED THAT THE V60 VENTILATOR WAS USED ON A PATIENT WITHOUT A FILTER. THE CUSTOMER INQUIRED WITH PHILIPS AND REQUESTED THE PROCEDURE FOR DECONTAMINATING THE VENTILATOR. THE REMOTE SERVICE ENGINEER (RSE) INFORMED THE CUSTOMER THAT THERE IS NO PHILIPS-APPROVED CLEANING METHOD FOR THE V60 AIR PATH. THE RSE PROVIDED THE CUSTOMER WITH EMAIL FROM THE PRODUCT SUPPORT ENGINEER (PSE), FOR THE SUGGESTED CLEANING PROCEDURE. THE PSE RECOMMENDED THAT THE DEVICE BE QUARANTINED FOR 72 HOURS (AND ADDING A SIGNIFICANT SAFETY MARGIN), AND REPLACE THE AIR INLET AND COOLING FAN FILTER ALONG WITH A COMPLETE WIPE DOWN OF ALL REACHABLE SURFACES. THE APPROVED DISINFECTING AGENTS FOR THE V60 WERE LISTED AS "62% TO 72% ETHANOL, SOLUTION OF 1 PART 5% SODIUM HYPOCHLORITE (BLEACH) DILUTED IN 9 PARTS DEIONIZED WATER, 3% HYDROGEN PEROXIDE." THE PSE REFERENCE THE CDC (CENTERS FOR DISEASE CONTROL AND PREVENTION), THAT COVID-19 CANNOT SURVIVE ON NON-POROUS SURFACES FOR MORE THAN 72 HOURS. THE PSE ALSO NOTED THAT ONE OPTION FOR THE CUSTOMERS, WAS TO REPLACE ALL GAS PATH COMPONENTS: GAS DELIVERY SUBSYSTEM (GDS), BLOWER ASSEMBLY, GAS OUTLET PORT, PROXIMAL PORT (1/8-INCHES), WHITE NYLON BARBED FITTING, TUBING KIT. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357084 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown