BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-ANIM AIR OXYGEN BLENDER SMALL

    MDR report key: 9219344 · Received October 22, 2019

    Report

    Report Number
    3007409280-2019-00045
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    September 23, 2019
    Report Date
    September 25, 2019
    Manufacturer
    PRECISION MEDICAL, INC.
    Product Code
    CAN
    PMA / PMN Number
    K901831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DEVICE SENT IN DUE TO THE BLEEDER LEAKING MORE THAN NORMAL. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. TECHNICAL VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION FOUND THE DEVICE NEEDED A COMPLETED OVERHAUL AND REQUIRED RE-CALIBRATING. THE OVERHAUL WAS COMPLETED AND THE DEVICE WAS CALIBRATED TO OEM SPECIFICATION. THE ROOT CAUSE WAS DETERMINED TO BE AGED PARTS. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR THE BLEEDER LEAKS MORE THAN NORMAL. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014376 TRI-ANIM AIR OXYGEN BLENDER SMALL PRECISION MEDICAL OXYGEN REGULATOR CAN PRECISION MEDICAL, INC. FOTA1000

    Patients

    Seq Age Sex Outcome Treatment
    1