BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 20631090 · Received November 7, 2024

    Report

    Report Number
    2518422-2024-69007
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 18, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BENCH SERVICE ENGINEER (BSE) COULD NOT REPLICATE THE ALLEGED BACKUP ALAR FAILED ALARM AT THE BENCH REPAIR CENTER BUT WAS ABLE TO CONFIRM THAT A BACKUP ALARM FAILED ALARM WAS LOGGED IN THE DEVICE DIAGNOSTIC REPORT (DRPT). THE BSE DETERMINED THAT THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) MAY REQUIRE REPLACEMENT. THE BSE COMPLETED THE MC PCBA REPLACEMENT AT THE BENCH REPAIR FACILITY AS A PREVENTATIVE MEASURE TO ENSURE THE RESOLUTION OF THE BACKUP ALARM FAILURE ISSUE. FOLLOWING THE MC PCBA REPLACEMENT, THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED. THE BSE RESTORED THE DEVICE TO FACTORY SETTINGS AND CONFIRMED THAT THE DEVICE WAS FULLY FUNCTIONAL. 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 ON THE V60 VENTILATOR INDICATING A BACKUP ALARM FAILED ALARM OCCURRED. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE BENCH SERVICE ENGINEER (BSE) COULD NOT REPLICATE THE ALLEGED BACKUP ALAR FAILED ALARM AT THE BENCH REPAIR CENTER BUT WAS ABLE TO CONFIRM THAT A BACKUP ALARM FAILED ALARM WAS LOGGED IN THE DEVICE DIAGNOSTIC REPORT (DRPT). THE BSE DETERMINED THAT THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) MAY REQUIRE REPLACEMENT. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599434 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown