BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 16090898 · Received January 3, 2023

    Report

    Report Number
    2031642-2023-00019
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 2, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS A CORRECTION IN RESPONSE TO CORRECTIVE ACTIONS TAKEN BY THE LEGAL MANUFACTURER. THE MANUFACTURER SITE NUMBER WAS INCORRECTLY SELECTED RESULTING IN INCORRECT REPORT NUMBERS. A NEW MDR WITH THE CORRECT MANUFACTURER SITE SELECTED HAS BEEN SUBMITTED UNDER MANUFACTURER REPORT # 2518422-2023-16113.

    Additional Manufacturer Narrative · 0

    H10: PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR, INDICATING THAT THE USER INTERFACE (UI) WAS NOT TURNING ON. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT HARM REPORTED. MULTIPLE GOOD FAITH EFFORTS WERE MADE TO RETRIEVE DEVICE EVALUATION, REPAIR, AND OPERATIONAL STATUS ON 03/07/2023, 03/14/2023, 03/21/2023, 03/28/2023, AND 04/05/2023, HOWEVER, YIELDED NO RESPONSE FROM THE CUSTOMER. IT IS UNKNOWN IF ANY PARTS OR REPAIRS HAVE BEEN CONDUCTED. THE COMPLAINT WILL BE PROCESSED FOR CLOSURE. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H11:UPDATED CONTACT INFORMATION, CONTACT OFFICE ENTITY, AND MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS A KEY PANEL FAILURE. AT THIS TIME, IT IS UNKNOWN IF THERE IS ANY PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED, AND THERE IS NO REPORTED PATIENT OR USER HARM. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209384 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown