BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE LARYNGOSCOPE SINGLE USE MAC 3

    MDR report key: 4682084 · Received April 10, 2015

    Report

    Report Number
    1718887-2015-00008
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    March 12, 2015
    Report Date
    December 19, 2016
    Manufacturer
    CAREFUSION
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON ORIGINAL RECEIPT OF THE COMPLAINT, IT WAS INDICATED THAT A SAMPLE WAS AVAILABLE FOR INVESTIGATION. TO DATE, NO SAMPLE HAS BEEN RECEIVED. IF A SAMPLE IS RECEIVED, A FULL EVALUATION WILL BE CONDUCTED ON THE SAMPLE AND AN UPDATE WILL BE PROVIDED TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER STATED "PATIENT WAS BEING PREPPED FOR INTUBATION. WHEN THE SINGLE USE VITAL SIGNS STEELITE MACINTOSH BLADE #3 WAS ATTACHED TO THE SINGLE USE BOMIMED  FIBER OPTIC LARYNGOSCOPE HANDLE, THE LIGHT DID NOT INITIALLY ILLUMINATE DESPITE TROUBLESHOOTING (REMOVE AND REATTACH BLADE AND CLOSE/OPEN BLADE/HANDLE AT PIVOT POINT). ONCE THE LIGHT FLICKERED, IT WOULD NOT STAY ON. WHEN THE BLADE WAS INSERTED INTO THE PATIENT¿S MOUTH, THE LIGHT TURNED OFF COMPLETELY PREVENTING USE AND VISUALIZATION OF THE PATIENT¿S VOCAL CORDS. THE STRUCTURAL STABILITY OF THE BLADE-HANDLE ATTACHMENT ALSO SEEMED POOR (SIGNIFICANT LATERAL MOVEMENT OF BLADE)." NO PATIENT HARM. SAMPLE IS AVAILABLE. (B)(6) 2015 EMAIL RECEIVED STATING-BELOW IS THE CUSTOMER¿S RESPONSE FOR ADDITIONAL INFORMATION:  ALTHOUGH WE HAVE NO DETAILS AS TO DROP IN PATIENT¿S OXYGEN LEVEL OR DELAY IN INTUBATION, THERE WAS NO APPARENT HARM TO THE PATIENT.  NO WE DO NOT HAVE ANY FURTHER INFORMATION REGARDING THE OPERATOR OF THE DEVICE, PATIENT DEMOGRAPHICS, THE REPORTER OF THE COMPLAINTS CREDENTIALS THAT WOULD ASSIST WITH THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238967 BLADE LARYNGOSCOPE SINGLE USE MAC 3 LARYNGOSCOPE, RIGID CCW CAREFUSION 4603 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention