BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 14406852 · Received May 16, 2022

    Report

    Report Number
    2031642-2022-01311
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    May 2, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE/PROBLEM WAS IDENTIFIED AND DISCOVERED ON (B)(6) 2022 DURING TESTING PRIOR TO PUTTING UNIT ON A PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER REACHED OUT TO TECHNICAL SUPPORT WITH REPORTS OF THE V60, ALARMING LOW TIDAL VOLUME, AND CO2 REBREATHING HAZARD. NO REPORTED PATIENT OR USER HARM OR IMPACT. IT IS UNKNOWN IF THE VENTILATOR WAS BEING USED ON A PATIENT AT THE TIME OF THE REPORTED EVENT, HOWEVER, THERE WAS NO PATIENT HARM REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED. BASED ON INFORMATION RECEIVED THE GAS DELIVERY SYSTEM (GDS) WILL BE NEEDED TO RESOLVE THE ISSUE. A PHILIPS BIOMEDICAL EQUIPMENT TECH (BIOTECH) WAS DEPLOYED TO THE FACILITY. CONFIRMED THE REPORTED ISSUE AND INSTALLED NEW GDS. PER BIOTECH, THE GDS WAS INSTALLED AND THE DEVICE FUNCTIONING AS EXPECTED. BIOTECH REPAIRED THE UNIT, AND THE UNIT WAS RETURNED TO SERVICE. BASED ON INFORMATION PROVIDED, THE CUSTOMER¿S ALLEGED MALFUNCTION WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427866 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown