BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 13560855 · Received February 18, 2022

    Report

    Report Number
    2031642-2022-00489
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    February 7, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION REGARDING THE DEVICE REPAIR INFORMATION. TO DATE NO FURTHER DETAILS HAVE BEEN RECEIVED. THE SERVICE HISTORY RECORD WAS REVIEWED AND FOUND THAT ANOTHER CASE WAS CREATED WHERE IT STATES THAT THE POWER SUPPLY WAS REPLACED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE UNIT HAS POWER FAILURE. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT, BUT THERE WAS NO PATIENT HARM REPORTED. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND STATES UNIT IS HAVING POWER ISSUES. WENT THROUGH POWER TROUBLESHOOTING WITH THE CUSTOMER. VERIFY POWER SUPPLY, A) WITH AC POWER DISCONNECTED, REMOVE J1 FROM PM PCBA, B) RECONNECT AC POWER, C) VERIFY THAT 24V IS PRESENT BETWEEN THE ORANGE AND BROWN WIRES ON THE POWER SUPPLY HARNESS CONNECTOR, D) IF 24V IS PRESENT, REPLACE THE PM PCBA, E) IF 24V IS NOT PRESENT, GO TO THE NEXT STEP. VERIFY THAT AC POWER IS PRESENT, A) DISCONNECT AC POWER, B) REMOVE EMI SHROUD, C) RECONNECT AC POWER, D) VERIFY THAT AC VOLTAGE IS PRESENT BETWEEN THE BLUE AND BROWN WIRES COMING FROM THE AC INLET, E) IF AC POWER IS PRESENT, REPLACE THE POWER SUPPLY. CUSTOMER CONFIRMED AC POWER AT AC INLET. CUSTOMER REQUESTING PART NUMBER AND PRICE FOR POWER SUPPLY. PRODUCT SUPPORT PROVIDED THE INFORMATION TO THE CUSTOMER. PATIENT INFORMATION AND REPAIR INFORMATION WERE REQUESTED FROM THE CUSTOMER, BUT NO RESPONSE WAS RECEIVED. FURTHER INFORMATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6460 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown