BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17218709 · Received June 28, 2023

    Report

    Report Number
    2518422-2023-14428
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 9, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR, INDICATING THAT THE DEVICE WAS EXPERIENCING A 35 VOLT POWER FAILURE. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. THE REMOTE SERVICE ENGINEER (RSE) RECOMMENDED CHECKING IF THE DEVICE REQUIRED A REPLACEMENT POWER MANAGMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE AUTHORIZED SERVICE PROVIDER (ASP) RECEIVED, IT WAS STATED THAT THE DIAGNOSTIC REPORT (DRPT) FOR THE DEVICE WAS NOT DOWNLOADED OR AVAILABLE. IT WAS DETERMINED THAT IT WAS NOT THE PM PCBA CAUSING THE ERROR, BUT THE MOTOR CONTROLLER (MC) PCBA. THE ASP STATED THE DEVICE WAS OUT PHILIPS FACTORY WARRANTY PERIOD. THE DEVICE WAS, HOWEVER, WITHIN THE CUSTOMERS DEVICE DEALER COMPANY WARRANTY PERIOD, SO THE CUSTOMER OPTED TO GO WITH 3RD PARTY SERVICE FROM THE DEALER COMPANY ENGINEERS FOR REPAIR. NO FURTHER WORK WAS PERFORMED BY PHILIPS AND NO FURTHER INFORMATION IS AVAILABLE REGARDING THE DEVICE ISSUE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725097 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown