BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 / AIR HOSES

    MDR report key: 10213422 · Received June 30, 2020

    Report

    Report Number
    2523148-2020-00002
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 30, 2020
    Manufacturer
    PRECISION MEDICAL INC
    Product Code
    BYX
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (2EA - 519012 (HOSE ASSY, AIR,DISS FHT, DISS FHX, 4') & (2EA - HOSE ASSY, O2, DISS FHT, DISS M, 4') RETURNED FOR INVESTIGATION. (2) HOSE ASSEMBLIES (519012) RETURNED TESTED - NO PROBLEM FOUND - FERRULES PROPERLY CRIMPED. (2) HOSE ASSEMBLIES (519174) RETURNED: (1) - FERRULE NOT CRIMPED PROPERLY (1) - FERRULE WAS MISSING WHICH WAS THE INCIDENT DEFINED IN THE DETAILS OF THE INCIDENT. HOSE ASSEMBLIES ARE FROM FEB 2018 IN EXCESS OF 2 YEARS OLD. IT IS UNKNOWN THE USE OF THE HOSE ASSEMBLY SINCE PURCHASED. REVIEW OF WORK INSTRUCTION DEFINES THE CRIMPING PROCESS AND TESTING PROCESS REVIEWED REPAIRS AND COMPLAINTS - NO OTHER COMPLAINTS OF THIS NATURE NOTE: ONLY ONE SHIPMENT OF 3EA (519174) HOSE ASSEMBLY WAS MADE IN FEB 2018. NO OTHER SHIPMENTS OF THIS ASSEMBLY RE-TRAIN ASSEMBLERS ON WORK INSTRUCTION MDFT120 "MEDICAL HOSE ASSEMBLY & TEST" AND MONITOR FOR ANY TRENDING

    Description of Event or Problem · 1

    AN AHS STAFF MEMBER REPORTED A NEAR MISS WHERE THEY WERE ALMOST INJURED DUE TO THE OXYGEN BLENDER HOSE DETACHING FROM THE WALL AND THE METAL COUPLING AT THE END SHOOTING OUT. THE STAFF MEMBER INVESTIGATED THAT BLENDER HOSE AS IT WAS MAKING A "HISSING" SOUND. WHEN THE STAFF TOUCHED IT, IT CAME APART AND CAME SHOOTING OUT OF THE WALL UNDER GREAT PRESSURE AND THE METAL COUPLING DEVICE FLEW TOWARDS THEM. FORTUNATELY, THE STAFF MEMBER WAS NOT INJURED AS THEY WERE WAS STANDING TO THE "SIDE" OF THIS DEVICE. HAD THEY BEEN IN FRONT OF IT, THEY COULD HAVE BEEN INJURED AS THE METAL PIECE FLEW WITH GREAT SPEED DUE TO THE PSI OF THE GAS FLOWING OUT. STAFF NOTICED ANOTHER OXYGEN BLENDER HOSE HISSING IN DIFFERENT LOCATION. STAFF WAS APPREHENSIVE TO MOVE THE HOSE DUE TO WHAT OCCURRED PREVIOUSLY. BIOMED CAME UP SHORTLY AFTER AND REPORTED THAT THE WRONG TYPE OF END WAS ON THE OXYGEN BLENDER HOSE. BIOMED SAID THIS TYPE OF END WAS NOT CSA APPROVED. THIS WAS THE SAME END THAT WAS ON THE ORIGINAL BLENDER MAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677967 O2 / AIR HOSES O2 / AIR HOSES BYX PRECISION MEDICAL INC 519012 / 519174 0212180001 / 0212180002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention