BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 18142143 · Received November 15, 2023

    Report

    Report Number
    2518422-2023-30442
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 4, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE FAULTY PART WAS RETURNED TO PHILIPS, AND THE FAILURE INVESTIGATION WAS PERFORMED. THE TECHNICIAN DOCUMENTED THE FOLLOWING CONCLUSION/ROOT CAUSE, "PRODUCT INVESTIGATION LAB (PIL) DID CONFIRM THE PRESENCE OF AN OVP (OVER VOLTAGE PROTECTION) CIRCUIT FAILURE ALARM. DIAGNOSTIC CODE 1127 OVP CIRCUIT FAILED WAS LIKELY CAUSED BY AN OVER VOLTAGE CONDITION RESULTING IN DAMAGE TO C148 AND U34. U34 WAS DETERMINED TO BE DAMAGED DUE TO THE ABSENCE OF VOLTAGE ON PIN 1, WHICH IS THE POSITIVE SUPPLY VOLTAGE OF THE IC (INTEGRATED CIRCUIT), DESPITE THE VOLTAGE BEING PRESENT AT C162. THIS ABSENCE OF VOLTAGE SUGGESTS INTERNAL DAMAGE TO THE U34 PREVENTING THE COMPLETION OF THE CIRCUIT."

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE SERVICE ENGINEER, REPORTING THAT THE V60 VENTILATOR DISPLAYED A 1127 (CHECK VENT: OVP CIRCUIT FAILED) ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND OBSERVED THAT THE V60 VENTILATOR DISPLAYED A 1127 (CHECK VENT: OVP CIRCUIT FAILED) ERROR CODE. THE FSE THEN REPLACED THE MOTOR CONTROL (MC) BOARD TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321915 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown