BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EQUIPLITE MTL DISP MILL 1

    MDR report key: 3854107 · Received March 18, 2014

    Report

    Report Number
    1044475-2014-00069
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 25, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED VIA MEDWATCH. THE CUSTOMER ALLEGES THAT A PT NEEDED EMERGENCY INTUBATION. A DISPOSABLE MILLER 1 BLADE WAS OBTAINED FROM THE CODE CART. THE BLADE DID NOT WORK (LIGHTING ISSUE) ON EITHER THE RUSCH HANDLE OR AFTER CHANGING THE BATTERIES. THE PT WAS INTUBATED WITH ANOTHER BLADE ATTACHED TO A HANDLE. THERE WAS NO REPORT OF PT HARM OR INJURY. REF UF/IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157896 RUSCH EQUIPLITE MTL DISP MILL 1 LARYNOGOSCOPE HANDLE CCW TELEFLEX 1209812

    Patients

    Seq Age Sex Outcome Treatment
    1