BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11849353 · Received May 19, 2021

    Report

    Report Number
    2031642-2021-03764
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102054. B4:19AUG2021. BASED UPON THE INFORMATION PROVIDED, THE DEVICE WAS IN CLINICAL USE PROVIDING THERAPY AT THE TIME OF THE EVENT REPORTED. NO HARM OR INJURY HAS BEEN INDICATED OR ALLEGED. THE INTERNATIONAL SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM. THE CUSTOMER DECIDED TO USE OTHER CHANNEL TO REPAIR THIS UNIT. PHILIPS DID NOT SERVICE THIS UNIT. NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION, THE CUSTOMER REPORTED THAT THE ISSUE WAS DISCOVERED DURING PREVENTATIVE MAINTENANCE, AND THE UNIT WAS NOT IN USE ON THE PATIENT. THEREFORE, THIS COMPLAINT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS BY A CUSTOMER THAT THE UNIT'S TOUCH SCREEN FAILED. BASED UPON THE INFORMATION PROVIDED, THE DEVICE WAS NOT IN CLINICAL USE OR PROVIDING THERAPY AT THE TIME OF THE EVENT REPORTED. NO HARM OR INJURY HAS BEEN INDICATED OR ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743288 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown