BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17267892 · Received July 6, 2023

    Report

    Report Number
    2518422-2023-14947
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 28, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ISSUE OCCURRED DURING PRE-USE SET-UP. THERE WAS NO REPORT OF HARM. THE BIOMEDICAL ENGINEER (BME) EVALUATED THE DEVICE AND CONFIRMED THE REPORTED PROBLEM. THE DIAGNOSTIC CODE 1127 (OVP CIRCUIT FAILED) WAS VERIFIED IN THE DEVICE LOG, INDICATING THE 12/3.3-VOLT OVP CIRCUIT DID NOT DETECT A 3.3-VOLT OVER-VOLTAGE CONDITION PROPERLY. THE BME REFERENCED THE V60 SERVICE MANUAL TO DETERMINE REPLACEMENT OF THE MOTOR CONTROL (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE DEVICE WAS OPERATIONAL AND RETURNED TO SERVICE AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. ALTHOUGH REQUESTED, THE DEFECTIVE PARTS WERE NOT RECEIVED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE PART IS RECEIVED AND EVALUATED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM CUSTOMER BIOMED, REPORTING AN OVERVOLTAGE PROTECTION CIRCUIT FAILURE (OVP) MESSAGE OCCURRED ON THE V60 VENTILATOR. IT IS NOT KNOWN WHETHER THE DEVICE WAS IN CLINICAL USE. THERE WAS NO REPORT OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973382 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown