BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH TRUMR SET: HDL+ MIL 1,2,3 MAC 2,3,4

    MDR report key: 8746812 · Received June 30, 2019

    Report

    Report Number
    8030121-2019-00054
    Event Type
    Malfunction
    Date Received
    June 30, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 6, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. MANUFACTURING SITE REPORTS "LIGHT TESTING TEST HAD BEEN PERFORMED ON PRODUCT AS PER FINAL INSPECTION CHECKLIST # FRM-001364 AND PRODUCT HAD QUALIFIED THE TEST. LIGHT WAS CONSTANT AND GLOWING ENOUGH WITHOUT FLICKERING. NO LIGHT ISSUE WAS NOT OBSERVED. WE HAVE COVERED ALL THE BATTERY CARTRIDGE AND BLADE IN THE LIST TEST, BUT NO SUCH THINGS OBSERVED RAISED BY USER. THERE MIGHT BE AN ISSUE OF LOOSE HANDLE AFTER FITMENT OF BATTERY CARTRIDGE. THIS SITUATION WILL LEAD THE LIGHT OR ELECTRICAL FAILURE. THIS INVESTIGATION SHOWS THAT CUSTOMER FAILURE WAS NOT CONFIRM." THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "NOT ALL BLADES IN THE SET ARE WORKING PROPERLY, WITH MINIMUM ONE BLADE THERE IS NO CONSTANT LIGHT." ISSUE DETECTED DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "NOT ALL BLADES IN THE SET ARE WORKING PROPERLY, WITH MINIMUM ONE BLADE THERE IS NO CONSTANT LIGHT." ISSUE DETECTED DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540424 RUSCH TRUMR SET: HDL+ MIL 1,2,3 MAC 2,3,4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 180801

    Patients

    Seq Age Sex Outcome Treatment
    1