BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 19992387 · Received August 15, 2024

    Report

    Report Number
    2518422-2024-51656
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 5, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE CUSTOMER RECEIVED, THE SERIAL NUMBER (B)(6) OF THE V60 VENTILATOR WAS PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PLACED AN ORDER FOR A REPLACEMENT BLOWER ASSEMBLY. IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE CUSTOMER RECEIVED, THE SERIAL NUMBER OF THE V60 VENTILATOR WAS PROVIDED. IN A GFE RESPONSE FROM THE CUSTOMER RECEIVED, IT WAS STATED THAT THE ORDERED BLOWER ASSEMBLY HAD BEEN RECEIVED, BUT THE REPAIR HAD NOT BEEN COMPLETED YET. THE DEVICE REMAINED OUT OF USE. IN A GFE RESPONSE FROM THE CUSTOMER RECEIVED ON 03SEP2024, THE CUSTOMER CONFIRMED THAT THE BLOWER ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS RETURNED TO SERVICE FOLLOWING THE REPAIR. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A HIGH BLOWER TEMPERATURE ALARM. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER PLACED AN ORDER FOR A REPLACEMENT BLOWER ASSEMBLY. IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE CUSTOMER RECEIVED, IT WAS STATED THAT THE ORDERED BLOWER ASSEMBLY HAD BEEN RECEIVED, BUT THE REPAIR HAD NOT BEEN COMPLETED YET. THE DEVICE REMAINED OUT OF USE. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619735 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown