BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EQUIPLITE DISP METAL MAC 3

    MDR report key: 3963196 · Received May 20, 2014

    Report

    Report Number
    1044475-2014-00135
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND VISUAL INSPECTION WAS PERFORMED. THE ELECTRICAL CIRCUIT WIRE TRACK IS BROKEN APPROXIMATELY THE SAME DISTANCE DISTALLY AND PROXIMALLY OF THE BLADE LENGTH. DIMENSIONAL AND FUNCTIONAL INSPECTIONS OF THE PRODUCT INVOLVED IN THE COMPLAINT WERE NOT CONDUCTED SINCE THE COMPLAINT WAS NOT RELATED TO A DIMENSIONAL AND FUNCTIONAL NONCONFORMITY. A CONCLUSION CODE COULD NOT BE CHOSEN AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE COULD NOT BE ESTABLISHED. THE CIRCUMSTANCES OF THE PACKAGING, SHIPPING AND HANDLING OF THE DEVICE IS UNK; THEREFORE, IT IS UNK IF THIS CONTRIBUTED TO THE REPORTED DEFECT. NO CORRECTIVE PREVENTATIVE ACTIONS WILL BE ASSIGNED. THERE WILL HOWEVER BE CONTINUED MONITORING AND TRENDING RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CLINICIAN WAS ATTEMPTING TO INTUBATE A PATIENT AND THE BLADE LIGHT PIPE COMPLETELY BROKE WHICH RESULTED IN A DISRUPTION OF LIGHT TRANSMISSION. THE PIPE BUNDLE BROKE IN THE CURVE AS THE BUNDLE WAS LEAVING THE BASE OF THE BLADE. THERE WAS NO REPORT OF BROKEN PIECES OF PLASTIC ENTERING THE PATIENT'S MOUTH. THE CLINICIAN REPLACED THE BROKEN BLADE WITH ANOTHER FUNCTIONING BLADE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298551 RUSCH EQUIPLITE DISP METAL MAC 3 CCW TELEFLEX 1401732

    Patients

    Seq Age Sex Outcome Treatment
    1