BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21044968 · Received December 30, 2024

    Report

    Report Number
    2518422-2024-075736
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 24, 2024
    Report Date
    January 13, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00884838010970
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WAS PERFORMED WITH THE KEY MARKET (KM), AND THE RESPONDER REPORTED ON 30DEC2024 THAT THERE WAS NO ISSUE WITH THE DEVICE. NO REPAIR WAS PERFORMED ON THE DEVICE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V200 VENTILATOR COULD NOT BE CONNECT TO HEALTHCARE INFORMATION SYSTEM (HCIS). THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. INVESTIGATION ONGOING / RESOLUTION PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090320 RESPIRONICS VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. V200 00884838010970

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown