BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 16146042 · Received January 12, 2023

    Report

    Report Number
    2031642-2023-00136
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 16, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    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

    INITIAL REPORTER: (B)(6).

    Additional Manufacturer Narrative · 0

    H10: INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE RESOLUTION OF THE EVENT. MULTIPLE GOOD FAITH EFFORTS WERE MADE TO RETRIEVE DEVICE EVALUATION, REPAIR, AND OPERATIONAL STATUS ON 12/22/2022, 01/11/2023, 01/19/2023, 01/25/2023, 02/01/2023, 02/07/2023, 02/14/2023, 02/21/2023, 02/28/2023, AND 03/08/2023, 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.

    Additional Manufacturer Narrative · 0

    H10: THE KEY MARKET REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. H11:UPDATED CONTACT INFORMATION, CONTACT OFFICE ENTITY, AND MANUFACTURING SITE.

    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 # 2518422-2023-17696.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE FIELD SERVICE ENGINEER (FSE), REPORTING THAT THE V60 VENTILATOR HAD LOW SCREEN BRIGHTNESS. IT WAS UNKNOWN HOW THE ISSUE WAS FOUND. NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573903 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown