BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11637810 · Received April 8, 2021

    Report

    Report Number
    2031642-2021-03303
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 9, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)# K102985. B4:31AUG2021. MANUFACTURER'S PRODUCT SUPPORT ENGINEER (PSE) EVALUATED THE INCIDENT. THE KEYPAD WAS SUCCESSFULLY REPLACED ON THE DEVICE AND THE DEVICE RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE V60 TOUCHSCREEN IS NOT RESPONDING AND WILL NOT PASS CALIBRATION. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM/IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532984 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1