BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 18837715 · Received March 5, 2024

    Report

    Report Number
    2518422-2024-11689
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 13, 2024
    Report Date
    June 12, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    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

    THE CUSTOMER CALLED IN TO REPORT THE V60 WOULD NOT TURN ON. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT A FIELD CHANGE ORDER (FCO) WAS IMPLEMENTED AND THEN THE DEVICE WOULD NOT TURN ON. THE CUSTOMER REQUESTED ONSITE SERVICE TO VERIFY THE FCO IMPLEMENTATION AND IF THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) REPLACED FROM THE FCO WAS DEFECTIVE. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE FOR FURTHER INVESTIGATION AND DETERMINED THAT THE POWER SUPPLY AND POWER CORD REQUIRED A REPLACEMENT. THE FSE REPLACED BOTH THE POWER SUPPLY AND POWER CORD AND CONFIRMED THE REPORTED ISSUE HAD BEEN RESOLVED. THE FSE REPLACED THE POWER SUPPLY AND POWER CORD TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE UNIT WOULD NOT TURN ON. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER CALLED IN TO REPORT THE V60 WOULD NOT TURN ON. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT A FIELD CHANGE ORDER (FCO) WAS IMPLEMENTED AND THEN THE DEVICE WOULD NOT TURN ON. THE CUSTOMER REQUESTED ONSITE SERVICE TO VERIFY THE FCO IMPLEMENTATION AND IF THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) REPLACED FROM THE FCO WAS DEFECTIVE. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583355 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown