BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC

    MDR report key: 11611871 · Received April 3, 2021

    Report

    Report Number
    3012307300-2021-02800
    Event Type
    Malfunction
    Date Received
    April 3, 2021
    Report Date
    May 25, 2021
    Product Code
    BTL
    UDI-DI
    35019315107263
    PMA / PMN Number
    K123957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. DURING THE EVALUATION OF THE DEVICE, THE TIDAL VOLUME KNOB RETRACTS FROM ITS EXTREME TO 1000ML ON MAX AND FROM 150ML ON MIN. THE TUBING ARRANGEMENT WAS INCORRECT WHICH WAS CAUSED BY MANUFACTURING. THE TUBING ON THE ROTARY FLOW VALVE WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL VENTILATOR HAD ISSUES WITH THE TIDAL VOLUME. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509125 PNEUPAC VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) BTL P310NUS 35019315107263

    Patients

    Seq Age Sex Outcome Treatment
    1