BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 16511685 · Received March 9, 2023

    Report

    Report Number
    2518422-2023-06475
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 9, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE CUSTOMER CALLED IN TO REPORT "NO OXYGEN INHALATION" WAS DISPLAYED WHEN THE NON-INVASIVE VENTILATOR TURNED ON. MULTIPLE GOOD FAITH EFFORTS WERE MADE TO RETRIEVE DEVICE EVALUATION, REPAIR, AND OPERATIONAL STATUS ON (B)(6)2023, (B)(6)2023 AND (B)(6)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

    INITIAL REPORTER NAME AND ADDRESS:: REPORTING INSTITUTION PHONE: (B)(6). REPORTER PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 INDICATING THAT WHEN THE NON-INVASIVE VENTILATOR WAS TURNED ON, AN ERROR MESSAGE OF NO OXYGEN INHALATION WAS DISPLAYED. IT WAS REPORTED THERE WAS PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550095 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown