BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12160526 · Received July 13, 2021

    Report

    Report Number
    2031642-2021-04326
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 17, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B4: (B)(6) 2021. THE DEVICE WAS EVALUATED BY THE CUSTOMER'S BIO-MEDICAL ENGINEER WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED 1105-ALARM LED FAILED ERROR CODE IN THE EVENT LOG. THE REPORTED PROBLEM WAS TRACED TO A FAULTY POWER SWITCH OVERLAY. THE CUSTOMER'S BIO-MED REPLACED THE POWER SWITCH OVERLAY TO RESOLVE THE ISSUE. THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED TESTING. FOLLOWING THE REPAIR, THE DEVICE WAS PLACED BACK INTO SERVICE.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 13JUL2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD AN ALARM LED (LIGHT-EMITTING DIODE) FAILURE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055511 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1