BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER

    MDR report key: 20487991 · Received October 18, 2024

    Report

    Report Number
    3000219639-2024-00114
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 6, 2024
    Report Date
    November 18, 2024
    Manufacturer
    SALTER LABS
    Product Code
    CCW
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    H6: (APPROPRIATE TERM/CODE NOT AVAILABLE): LARYNGOSCOPE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 18 OCT 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 (E): (APPROPRIATE TERM/CODE NOT AVAILABLE): DIFFICULTY [IN] CONTROLLING [THE] PATIENT'S TONGUE. H6: (APPROPRIATE TERM/CODE NOT AVAILABLE): LARYNGOSCOPE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 18 NOV 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

    IT WAS REPORTED, DURING [PATIENT] RESUSCITATION [THE] DECISION [WAS] MADE TO INTUBATE DUE TO PERSISTENT HYPOXIA. THE INTUBRITE DISPOSABLE HANDLE [WAS] GIVEN TO [THE] FELLOW FOR INTUBATION, AND UPON ATTEMPT NOTICED THAT UNABLE TO VIEW. ON FURTHER INSPECTION [OF THE] LIGHT [IT WAS] NOTICED TO NOT BE TURNING ON WHEN ENGAGING BLADE. [THE] HANDLE [WAS] SWITCHED OUT FOR [A] DIFFERENT INTUBRITE HANDLE WITH SAME BLADE AND LIGHT FOUND TO BE OPERATIONAL. THE INFANT'S HYPOXIA IMPROVED AND DID NOT REQUIRE INTUBATION, BUT THIS FAILURE DID RESULT IN MULTIPLE INTRODUCTIONS OF FAULTY HANDLE. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    CHALLENGES DURING INTUBATION WERE REPORTED, DUE TO CURVED BLADE ON NEW PRODUCT CAUSING DIFFICULTY IN CONTROLLING THE PATIENT'S TONGUE. [(B)(4)]. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228442 MILLER MILLER O BLADE CCW SALTER LABS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown