BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED HOLDINGS LLC

    MDR report key: 15829902 · Received November 19, 2022

    Report

    Report Number
    1314417-2022-00022
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    September 1, 2022
    Report Date
    November 17, 2022
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE OF THE DEVICE DELAYED THE INTUBATION OF THE PATIENT. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Additional Manufacturer Narrative · 0

    FAILURE OF THE DEVICE DELAYED THE INTUBATION OF THE PATIENT. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. COMPLAINT CONFIRMED WITH CUSTOMER'S PHOTOS. REVIEWED THE COMPLAINT HISTORY FOR THE PART AND FOR THE PRODUCT FAMILY AND THERE WAS NO TRENDING ISSUE. PERFORMED A RISK ANALYSIS WHICH INDICATED THE SEVERITY RATING OF THE COMPLAINT IS 7/10. DETERMINED ROOT CAUSE TO BE USER ERROR OF NOT FULLY SEATING THE BLADE IN THE HANDLE. SENT RESOLUTION TO THE CUSTOMER.

    Description of Event or Problem · 0

    LARYNGOSCOPE BLADE BROKE OFF THE HANDLE DURING INTUBATION.

    Description of Event or Problem · 0

    LARYNGOSCOPE BLADE BROKE OFF THE HANDLE DURING INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255891 SUNMED HOLDINGS LLC ALL METAL F/O DISP MILLER SZ 2 CCW SUNMED HOLDINGS LLC 5-5336-02 215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other