BEUDAMED
    FDA Adverse Event Death Summary report: N

    RUSCH LITE BLADE - MILLER #2

    MDR report key: 2616501 · Received June 4, 2012

    Report

    Report Number
    1044475-2012-00055
    Event Type
    Death
    Date Received
    June 4, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 10, 2012
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION. THE RISK MANAGER AT (B)(6), INDICATED THAT THE BLADE USED IN THIS INCIDENT WAS USED WITH A LARYNGOSCOPE HANDLE THAT WAS NOT MANUFACTURED BY TELEFLEX. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED, VIA MEDWATCH, AS: THE PATIENT WENT INTO SUDDEN CARDIAC/RESPIRATORY ARREST. THE PHYSICIAN'S ATTEMPTS TO INTUBATE THE PATIENT WERE UNSUCCESSFUL. THE LIGHT ON THE BLADE WENT OUT DURING THE LIFTING STEP OF INTUBATION, AND/OR THE BLADE ACTUALLY BENT DOWNWARD. THERE WERE THREE DEVICES (LARYNGOSCOPE BLADES) USED ON ONE PATIENT DURING ONE EVENT RESULTING IN ONE DEATH. MDR# 1044475-2012-00051 - IS THE REPORTING NUMBER FOR THE DEATH OF THE PATIENT. MDR# 1044475-2012-00056 - IS THE REPORTING NUMBER FOR THE OTHER DEVICE (LARYNGOSCOPE BLADE) USED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH LITE BLADE - MILLER #2 LARYNGOSCOPE BLADE CCW TELEFLEX 0503001

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death (MDR#1044475-2012-00051)| RUSCH LARYNGOSCOPE MACINTOSH #3| RUSCH LARNGOSCOPE MILLER #2| (MDR#1044475-2012-00056)