BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EQUIPLED BLADEMAC 4

    MDR report key: 10236216 · Received July 6, 2020

    Report

    Report Number
    8030121-2020-00091
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 21, 2020
    Report Date
    June 21, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTS "WE HAVE CONFIRMED THE FUNCTIONAL TEST WITH TWO DIFFERENT HANDLES TO PERFORM THE LIGHT TESTING OF BLADES AND NOTICED THAT ALL THE BLADES QUALIFIED IN THE FUNCTIONAL TESTING, THERE IS NOTHING WRONG WITH THE BLADES". THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 191201 AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THERE IS NO LIGHT ON THE BLADES AFTER FIXING THE BLADES ON THE HANDLES. IT WAS REPORTED THE FAILURE WAS DISCOVERED BEFORE INTUBATION AND THERE WAS NO HARM CAUSED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THERE IS NO LIGHT ON THE BLADES AFTER FIXING THE BLADES ON THE HANDLES. IT WAS REPORTED THE FAILURE WAS DISCOVERED BEFORE INTUBATION AND THERE WAS NO HARM CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698712 RUSCH EQUIPLED BLADEMAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 191201

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED| NONE REPORTED