BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11639428 · Received April 8, 2021

    Report

    Report Number
    2031642-2021-03322
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 10, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBLEM WAS OBSERVED DURING PREVENTATIVE MAINTENANCE, WHICH IS OUTSIDE OF CLINICAL USE AND THEREFORE, NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPLACED SOLENOID 3 & 4 AND THE UNIT SUCCESSFULLY PASSED PERFORMANCE VERIFICATION. THE UNIT IS LIMITED DUE TO BAD INTERNAL BATTERY. THE BIOMED STATED HE WILL GET IT REPLACED. THE FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE THE REPORTED ISSUE. THE FSE FOUND THE UNIT LOGGED MULTIPLE ERROR CODE 110A, POST PROX PRESSURE SENSOR AZ FAILED. THE FSE THEN VERIFIED PIN ALIGNMENT BETWEEN THE DATA ACQUISITION PCB AND SOLENOID. PER CODE 110A SUGGESTION AND AS A PREVENTATIVE MEASURE, THE FSE REPLACED SOLENOID 3 & 4. THE SOLENOID XVALVE #4 WAS TESTED, AND NO FAILURES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A MACHINE PRESSURE SENSOR AUTO ZERO FAILED ERROR. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM/IMPACT. THE CUSTOMER EVALUATED THE DEVICE WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE CALLER WAS NOT WITH THE DEVICE AT THE TIME OF THE CALL AND REQUESTED THAT A PHILIPS FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE TO PROVIDE ADDITIONAL ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529932 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown