BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 HOSES

    MDR report key: 9856064 · Received March 19, 2020

    Report

    Report Number
    2523148-2020-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 17, 2020
    Manufacturer
    PRECISION MEDICAL INC
    Product Code
    BYX
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRECISION MEDICAL INC EVALUATED THE RETURNED HOSE ASSEMBLY WHICH HAD A FITTING THAT WAS NOT DRILLED OUT CAUSING NO FLOW. AN ADDITIONAL INSPECTION OF ALL FITTINGS WAS PERFORMED RESULTING IN NO DISCREPANCIES. REVIEW OF COMPLAINTS INDICATES NO OTHER SIMILAR COMPLAINTS. SUPPLIER WAS NOTIFIED OF THE DEFECTIVE COMPONENT. THIS INCIDENT HAS BEEN DOCUMENTED IN THE COMPLAINT FILES FOR ANY TRENDING. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    NEW OXYGEN HIGH PRESSURE HOSE WAS FOUND TO BE NOT PATENT UPON FIRST USE. HOSE WAS ATTACHED TO AN AIR/O2 BLENDER. BLENDER WAS PLACED IN USE IN OUR NICU. PATIENT SAFETY NOT AFFECTED - AS SOON AS THE HOSES WERE PLUGGED IN THE BLENDER ALARMED AND THEY IMMEDIATELY TOOK IT OUT OF SERVICE AND PLACED THE PATIENT ON ANOTHER DEVICE. AFTER FURTHER INVESTIGATION THE RT SUPERVISOR FOUND THAT THE HOSE WAS BLOCKED. BLENDER WAS NOT MANUFACTURED BY PRECISION MEDICAL INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321730 O2 HOSES O2 HOSES BYX PRECISION MEDICAL INC HA-U1C4-01686 02202000081

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention