BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED LLC

    MDR report key: 14161273 · Received April 20, 2022

    Report

    Report Number
    1314417-2022-00015
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 20, 2022
    Manufacturer
    SUNMED LLC
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE LARYNGOSCOPE NOT STAYING LIT CAUSED THE INFANT TO BE RE-INTUBATED. THIS DELAYED TREATMENT AND 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

    THE LARYNGOSCOPE NOT STAYING LIT CAUSED THE INFANT TO BE RE-INTUBATED. THIS DELAYED TREATMENT AND 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 HISTORY FOR THIS PRODUCT FOR THE PAST 24 MONTHS REVIEWED. THERE ARE NO SIMILAR COMPLAINTS. WITHOUT RETURNED PRODUCT, LOT# OR PICTURES RETURNED, COMPLAINT CANNOT BE VERIFIED. SAMPLING PLAN IS IN PLACE TO CATCH DEFECTS. PART OF RECEIVING INSPECTION (RIR-0219) IS A FUNCTIONAL TEST "VERIFY ILLUMINATION OF BLADE WHEN ATTACHED TO HANDLE" THE IFU STATES: CHECK TO SEE THAT BOTH BULBS ARE LIT AND FUNCTIONING CORRECTLY - ENSURE THAT SPARE BLADES AND HANDLES ARE ALWAYS AVAILABLE IN CASE OF FAILURE OR EMERGENCY. RISK(RA-46): R6: REDUCED OR NO VISUALIZATION - LIGHT SOURCE NOT FUNCTIONAL - S=5 O=1 RPN=5. RPN < 25 THEREFORE RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    WOULD NOT STAY LIT DURING USE. INFANT HAD TO BE RE-INTUBATED WITH A DIFFERENT BLADE

    Description of Event or Problem · 0

    WOULD NOT STAY LIT DURING USE. INFANT HAD TO BE RE-INTUBATED WITH A DIFFERENT BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957037 SUNMED LLC GREENLINE F/O AMER MAC SZ 0 CCW SUNMED LLC 5-5231-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other