BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUBRITE

    MDR report key: 19767587 · Received July 17, 2024

    Report

    Report Number
    3000219639-2024-00064
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    SALTER LABS
    Product Code
    CCW
    UDI-DI
    00607411964411
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 17 JUL 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3000219639-2024-00063 FOR THE FIRST REPORT. IT WAS REPORTED, THE PHYSICIAN ATTEMPTED TO INTUBATE THE PATIENT; HOWEVER, THE LIGHT ON THE BLADE DID NOT WORK; THE BLADE WAS REPLACED WITH ONE THAT WORKED. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT WAS ADDITIONALLY REPORTED, THE DEFECTIVE BLADE WAS TESTED AFTER THE PATIENT WAS STABLE; IT WORKED SEVERAL TIMES BUT ALSO SHORTED OUT, AS IT WOULD "COME ON AND GO BACK OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172863 INTUBRITE MEDIUM SINGLE USE DISPOSABLE LARYNGOSCOPE HANDLE CCW SALTER LABS 2015.C 2023-01-19-ADMS 00607411964411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown