BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K083526

    MDR report key: 7490162 · Received May 7, 2018

    Report

    Report Number
    2518422-2018-01081
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959022744
    PMA / PMN Number
    K083526
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN EVALUATED BUT NOT REPAIRED.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S SENSOR BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332577 K083526 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054096 00606959022744

    Patients

    Seq Age Sex Outcome Treatment
    1