BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOMIMED

    MDR report key: 6520375 · Received April 25, 2017

    Report

    Report Number
    3003213883-2017-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    March 11, 2017
    Report Date
    April 25, 2017
    Manufacturer
    BOMIMED INC
    Product Code
    CCW
    Removal / Correction Number
    9071838-07/13/17-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    BOMIMED REQUESTED TO HAVE THE HANDLE RETURNED FOR FURTHER INVESTIGATION. QA DEPT TO CONDUCT FURTHER TESTING.

    Additional Manufacturer Narrative · 1

    BOMIMED REQUESTED TO HAVE THE HANDLE RETURNED FOR FURTHER INVESTIGATION. QA DEPT TO CONDUCT FURTHER TESTING.

    Description of Event or Problem · 1

    FAILED DURING AN INTUBATION ATTEMPT. THE CREW STATES THAT IT WAS LIKE A STROBE LIGHT. WHEN THE BLADE IS LOCKED INTO PLACE, THE LIGHT DOES NOT ACTIVATE, OR IT ACTIVATED DURING AN INTERMITTENTLY. MULTIPLE BLADES WERE ATTEMPTED, AND THE ATTACHMENT OF THE BLADE WAS NOT THE ISSUE (ACCORDING TO USER). THE BATTERIES WERE FULLY CHARGED, AND THE EQUIPMENT WAS BEING USED APPROPRIATELY. KING LT WAS PLACED WHILE TROUBLESHOOTING EQUIPMENT. CREW WAS UNABLE TO FIX FAILED LARYNGOSCOPE HANDLE. INTUBATION ATTEMPT WAS ABANDONED DUE TO FAULTY EQUIPMENT. THIS DID NOT IMPACT THE PATIENT OUTCOME.

    Description of Event or Problem · 1

    FAILED DURING AN INTUBATION ATTEMPT. THE CREW STATES THAT IT WAS LIKE A STROBE LIGHT. WHEN THE BLADE IS LOCKED INTO PLACE, THE LIGHT DOES NOT ACTIVATE, OR IT ACTIVATED DURING AN INTERMITTENTLY. MULTIPLE BLADES WERE ATTEMPTED, AND THE ATTACHMENT OF THE BLADE WAS NOT THE ISSUE (ACCORDING TO USER). THE BATTERIES WERE FULLY CHARGED, AND THE EQUIPMENT WAS BEING USED APPROPRIATELY. KING LT WAS PLACED WHILE TROUBLESHOOTING EQUIPMENT. CREW WAS UNABLE TO FIX FAILED LARYNGOSCOPE HANDLE. INTUBATION ATTEMPT WAS ABANDONED DUE TO FAULTY EQUIPMENT. THIS DID NOT IMPACT THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301410 BOMIMED LARYNGOSCOPE HANDLE, DISPOSABLE CCW BOMIMED INC OL-334L6 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention