BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17411018 · Received July 27, 2023

    Report

    Report Number
    2518422-2023-17259
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    January 10, 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

    E1: REPORTING INSTITUTION NAME: SHANGHAI CITY DONGSONG INTERNATIONAL EXPORT AND EXPORT TRADE CO. REPORTING ADDRESS STATE: (B)(6). REPORTING ADDRESS POSTAL: (B)(6). REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6). THIS REPORT IS BEING SUBMITTED AS PART OF A CORRECTIVE ACTION TO REPLACE MANUFACTURER REPORT # 2031642-2023-00304. ALL INFORMATION FROM THE ORIGINAL REPORT(S) HAS BEEN TRANSFERRED TO THIS REPORT.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A "PROXIMAL PRESSURE SENSOR AUTOZERO" ERROR MESSAGE WAS DISPLAYED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE AUTHORIZED SERVICE PROVIDER (ASP) ENGINEER CONFIRMED THE REPORTED PROBLEM AND FOUND THAT THE DATA ACQUISITION BOARD WAS FAULTY UPON CHECKING THE DEVICE. THE ASP ENGINEER REPLACED THE DATA ACQUISITION BOARD TO RESOLVE THE ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919780 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