BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11889243 · Received May 26, 2021

    Report

    Report Number
    2031642-2021-03843
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985 B4:02JUL2021 THE CUSTOMER REPLACED THE DATA ACQUISITION (DAQ) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) TO RESOLVE THE ISSUE FOUND DURING SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISPLAY NOT WORKING. THE CUSTOMER REPORTED THE UNIT BEEPED EVERY 1 OR 2 SECONDS AND WILL NOT POWER ON. THE CUSTOMER REPORTED THE UNIT WILL NOT POWER ON AND WAS ALARMING. THE CUSTOMER CONFIRMED THE LIQUID CRYSTAL DISPLAY (LCD) CABLE WAS CONNECTED TO THE WRONG PORT. THE CUSTOMER ALSO IDENTIFIED THE DATA ACQUISITION (DAQ) BOARD WAS MALFUNCTIONING, INFORMATION WAS NOT TRANSFERRING FROM (DAQ) BOARD TO THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE CUSTOMER WILL ORDER (DAQ) BOARD TO FIX PROBLEM AND PM KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785216 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1