BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20782371 · Received November 26, 2024

    Report

    Report Number
    2518422-2024-071852
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 5, 2024
    Report Date
    December 2, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE RESOLUTION OF THE EVENT. MULTIPLE GOOD FAITH EFFORTS (GFE) WERE PERFORMED FOR FURTHER DETAILS REGARDING THE EVENT; HOWEVER, THE CUSTOMER REPORTED THAT THE DEVICE HAS NOT BEEN REPAIRED, AND DID NOT PROVIDE ANY FURTHER DETAILS REGARDING THE EVENT. IN THE EVENT THAT PARTS ARE RETURNED OR IF NEW INFORMATION IS PROVIDED, THE COMPLAINT WILL BE REOPENED TO UPDATE THE INVESTIGATION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE BIOMEDICAL ENGINEER (BME), REPORTING THAT THE V60 VENTILATOR DISPLAYED AN OVER-VOLTAGE PROTECTION (OVP) ERROR CODE. IT WAS REPORTED THAT THE DEVICE WAS NOT IN CLINICAL USE WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT OR USER HARM REPORTED. THE BME NOTED THE FOLLOWING ERROR CODES, VENT 3.3V SUPPLY FAILED, MOTOR CONTROL PCBA ADC FAILED, 5V SUPPLY FAILED, 35V SUPPLY FAILED, AND OVP CIRCUIT FAILED. AS THE ERROR CODES ARE RELATED TO EACH OTHER, THE ISSUE IS CONSIDERED AN OVP CIRCUIT FAILED ISSUE. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441794 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown