BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 16418249 · Received February 22, 2023

    Report

    Report Number
    2518422-2023-05418
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 24, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE RESOLUTION OF THE EVENT. MULTIPLE GOOD FAITH EFFORTS WERE MADE TO RETRIEVE DEVICE EVALUATION, REPAIR, AND OPERATIONAL STATUS ON 01/30/2023, 02/08/2023, 02/15/2023, 02/21/2023, 03/01/2023, 03/08/2023, 03/14/2023 AND 04/11/2023, HOWEVER, YIELDED NO RESPONSE FROM THE CUSTOMER. IT IS UNKNOWN IF ANY PARTS OR REPAIRS HAVE BEEN CONDUCTED. THE COMPLAINT WILL BE PROCESSED FOR CLOSURE. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10 THE FIELD SERVICE ENGINEER (FSE) REPLACED THE FAULTY GAS DELIVERY SYSTEM (GDS) AND MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. 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 FROM THE SERVICE ENGINEER, REPORTING THAT THE V60 VENTILATOR HAD A CHECK VENT BLOWER TEMPERATURE TOO HIGH ERROR. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM REPORTED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319225 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown