BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 19260966 · Received May 7, 2024

    Report

    Report Number
    2518422-2024-25881
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    January 16, 2024
    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

    Additional Manufacturer Narrative · 0

    IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE AUTHORIZED SERVICE PROVIDER (ASP) RECEIVED ON 06MAY2024, IT WAS STATED THAT THE HOSPITAL EQUIPMENT DEPARTMENT HAD REMOVED THE BATTERY AND RESTORED THE DEVICE TO NORMAL USE AFTER REINSTATING ALTERNATING CURRENT (AC) POWER. CLARIFICATION IS BEING REQUESTED IN A GOOD FAITH EFFORT (GFE) ON IF A REPLACEMENT BATTERY WAS REINSTALLED INTO THE DEVICE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INFORMED THE AUTHORIZED SERVICE PROVIDER (ASP) THAT THE DEVICE DID NOT WORK FOLLOWING THE SHUTDOWN. IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE AUTHORIZED SERVICE PROVIDER (ASP) RECEIVED ON 06MAY2024, IT WAS STATED THAT THE HOSPITAL EQUIPMENT DEPARTMENT HAD REMOVED THE BATTERY AND RESTORED THE DEVICE TO NORMAL USE AFTER REINSTATING ALTERNATING CURRENT (AC) POWER. CLARIFICATION IS BEING REQUESTED IN A GOOD FAITH EFFORT (GFE) ON IF A REPLACEMENT BATTERY WAS REINSTALLED INTO THE DEVICE. IN A GFE RESPONSE FROM THE ASP RECEIVED ON 17MAY2024, IT WAS CONFIRMED THAT THE CUSTOMER HAD NOT REINSTALLED A BATTERY BEFORE CONNECTING THE DEVICE TO AC POWER TO RESOLVE THE ISSUE. 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 THAT THE DEVICE SHUTDOWN. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER INFORMED THE AUTHORIZED SERVICE PROVIDER (ASP) THAT THE DEVICE DID NOT WORK FOLLOWING THE SHUTDOWN. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439576 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown