BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21117718 · Received January 9, 2025

    Report

    Report Number
    2518422-2025-001383
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 30, 2024
    Report Date
    February 6, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838089297
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5 OF THE INITIAL REPORT SUBMITTED SHOULD HAVE STATED: PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT PATIENT DISCONNECT OCCURRED. IT WAS ALSO REPORTED THERE WERE LEAKS AND EXCESSIVE VOLUMES. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. H10: THE CUSTOMER INITIALLY REQUESTED AN INTERVENTION AND SOUGHT ADVICE IF A LOANER DEVICE IS POSSIBLE IF THE DEVICE NEEDS TO BE SENT TO A WORKSHOP. HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THIS CASE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO TRY TO OBTAIN FURTHER INFORMATION ABOUT THE REPORTED ISSUE, BUT NO RESPONSE HAS BEEN RECEIVED. THE COMPLAINT WILL BE PROCESSED FOR CLOSURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    BONJOUR, NOUS AVONS UN V60 EN PANNE (SN (B)(6)): SIGNAL UN DÉBRANCHEMENT PATIENT, DES FUITES ET DES VOLUMES DISPROPORTIONNÉS. POUVONS NOUS DÉCLENCHER UNE INTERVENTION SVP? ETANT LE SEUL EQUIPMENT DANS LE SERVICE, UN PRÊT EST IL ENVISAGEABLE SI L'ÉQUIPEMENT DOIT PARTIR EN ATELIER? MERCI À VOUS ET (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365578 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838089297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown