BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 16311630 · Received February 7, 2023

    Report

    Report Number
    2031642-2023-00426
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 11, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED THAT THE BATTERY HAD NO POWER AND THE DEVICE SHUT DOWN AUTOMATICALLY. THE FSE RE-PLUGGED THE ALTERNATING CURRENT AND THE DEVICE TURNED BACK ON. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. H11. UPDATED CONTACT INFORMATION AND CONTACT OFFICE ENTITY.

    Additional Manufacturer Narrative · 0

    REPORTING INSTITUTION PHONE NUMBER : (B)(6). REPORTER PHONE NUMBER : (B)(6).

    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 # 2518422-2023-18033.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE UNIT EXPERIENCED AN AUTOMATIC SHUTDOWN. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER CALLED THE REMOTE SERVICE ENGINEER (RSE) AND REPORTED THAT THE UNIT HAD EXPERIENCED AN AUTOMATIC SHUTDOWN. ONSITE SERVICE AND EVALUATION ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137340 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown