BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21307510 · Received February 4, 2025

    Report

    Report Number
    2518422-2025-011253
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 28, 2025
    Report Date
    April 14, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 21FEB2025, THE BENCH SERVICE ENGINEER (BSE) DETERMINED THAT THE DEVICE WOULD BE RETURNED TO THE CUSTOMER UNREPAIRED. THE CUSTOMER WAS UNRESPONSIVE TO THE SERVICE PROPOSAL PROVIDED FOR A REPLACEMENT SPEAKER ASSEMBLY AND FURTHER BENCH SERVICE, SO THE PROPOSAL WAS CANCELED, AND NO FURTHER REPAIR WAS COMPLETED. NO PARTS WERE INSTALLED, NO TOOLS WERE USED, AND NO FURTHER TESTING WAS PERFORMED. THE BSE PLACED A DEFECTIVE STICKER ON THE DEVICE BEFORE SHIPPING IT BACK, INDICATING TO THE CUSTOMER THAT THE DEVICE DOES NOT MEET SPECIFICATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SENT BACK IN TO A BENCH REPAIR CENTER. A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE, LETTING IT RUN FOR SEVERAL DAYS, BUT COULD NOT DUPLICATE ANY DEVICE ISSUE. THE BSE STATED THAT THEY WOULD ORDER A REPLACEMENT SPEAKER ASSEMBLY. ON 10APR2025, AT THE BENCH REPAIR CENTER, A BENCH SERVICE ENGINEER (BSE) REPLACED THE SPEAKER ASSEMBLY TO RESOLVE THE DEVICE ISSUE. FOLLOWING THE PART REPLACEMENT, THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED, CONFIRMING THAT IT WAS FULLY FUNCTIONAL. THE DEVICE WILL BE RETURNED TO THE CUSTOMER READY FOR USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SENT BACK IN TO A BENCH REPAIR CENTER. A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE, LETTING IT RUN FOR SEVERAL DAYS, BUT COULD NOT DUPLICATE ANY DEVICE ISSUE. THE BSE STATED THAT THEY WOULD ORDER A REPLACEMENT SPEAKER ASSEMBLY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    H11: THE BSE DETERMINED THAT THE SPEAKER ASSEMBLY (NOT THE CPU PCBA) WOULD REQUIRE REPLACEMENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE SPEAKER WAS MAKING A GARBLED SOUND. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE BY RUNNING THE DEVICE FOR SEVERAL DAYS OVER A WEEKEND AND OBSERVED THE SPEAKER ISSUE. THE BSE DETERMINED THAT THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WOULD REQUIRE REPLACEMENT. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53659 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown