BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20581082 · Received October 31, 2024

    Report

    Report Number
    2518422-2024-67289
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 20, 2024
    Manufacturer
    VISICU, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPLACED THE BATTERY 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 ERROR, "BATTERY FAILED" (DIAGNOSTIC CODE 1124), HAD OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE ERROR, "BATTERY FAILED" (DIAGNOSTIC CODE 1124), HAD OCCURRED. THE CUSTOMER REQUESTED THE PART NUMBER OF THE INTERNAL BATTERY TO ORDER AND REPLACE. RESOLUTION AND DISPOSITION ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886097 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT VISICU, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown