BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH POLARIS FO BLADE MAC 3

    MDR report key: 19870741 · Received July 31, 2024

    Report

    Report Number
    3011137372-2024-00115
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 4, 2024
    Report Date
    July 5, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    UDI-DI
    14026704629692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 4150130 RUSCH POLARIS FO BLADE MAC 3 FOR INVESTIGATION. VISUAL EXAMINATION DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES. THE DEVICE APPEARED TYPICAL. FUNCTIONAL INSPECTION WAS PERFORMED BY ATTACHING THE BLADE TO A KNOWN GOOD RUSCH DISPOLED LAB INVENTORY HANDLE. TO SWITCH ON, THE BLADE WAS PULLED UP AND THE BLADE WAS ABLE TO PROPERLY ILLUMINATE. THE MANUFACTURING DHR FILE WAS REVIEWED BASED ON THE LOT REPORTED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE BLADE PASSED ALL NECESSARY RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 10/2023 AND IS APPROXIMATELY 10 MONTHS OLD. THE COMPLAINT CANNOT BE CONFIRMED. FUNCTIONAL TESTING CONFIRMED THAT THE BLADE WAS ABLE TO PROPERLY ILLUMINATE WITH MULTIPLE LAB INVENTORY HANDLES ATTACHED. THE RETURNED BLADE WAS PUT UNDER AN APPLIED LOAD AND THE LIGHT DID NOT TURN OFF, DIM, OR FLICKER AT ANY POINT. NO ISSUES WERE IDENTIFIED WITH THE LIGHT FUNCTION OF THE BLADE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED AS THERE WAS NO FAULT FOUND WITH THE DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 4150130 RUSCH POLARIS FO BLADE MAC 3 FOR INVESTIGATION. VISUAL EXAMINATION DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES. THE DEVICE APPEARED TYPICAL. FUNCTIONAL INSPECTION WAS PERFORMED BY ATTACHING THE BLADE TO A KNOWN GOOD RUSCH DISPOLED LAB INVENTORY HANDLE. TO SWITCH ON, THE BLADE WAS PULLED UP AND THE BLADE WAS ABLE TO PROPERLY ILLUMINATE. THE MANUFACTURING DHR FILE WAS REVIEWED BASED ON THE LOT REPORTED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT THE BLADE PASSED ALL NECESSARY RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 10/2023 AND IS APPROXIMATELY 10 MONTHS OLD. THE COMPLAINT CANNOT BE CONFIRMED. FUNCTIONAL TESTING CONFIRMED THAT THE BLADE WAS ABLE TO PROPERLY ILLUMINATE WITH MULTIPLE LAB INVENTORY HANDLES ATTACHED. THE RETURNED BLADE WAS PUT UNDER AN APPLIED LOAD AND THE LIGHT DID NOT TURN OFF, DIM, OR FLICKER AT ANY POINT. NO ISSUES WERE IDENTIFIED WITH THE LIGHT FUNCTION OF THE BLADE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED AS THERE WAS NO FAULT FOUND WITH THE DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THIS PADDLE HAS A VERY SHORT LIGHT AND WHEN A PATIENT MUST BE INTUBATED, THE LIGHT IS NOT POWERFUL ENOUGH TO BE ABLE TO SEE THE LARYNX AND INTUBATE CORRECTLY. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THIS PADDLE HAS A VERY SHORT LIGHT AND WHEN A PATIENT MUST BE INTUBATED, THE LIGHT IS NOT POWERFUL ENOUGH TO BE ABLE TO SEE THE LARYNX AND INTUBATE CORRECTLY. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THIS PADDLE HAS A VERY SHORT LIGHT AND WHEN A PATIENT MUST BE INTUBATED, THE LIGHT IS NOT POWERFUL ENOUGH TO BE ABLE TO SEE THE LARYNX AND INTUBATE CORRECTLY. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886056 RUSCH POLARIS FO BLADE MAC 3 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL AB2310006 14026704629692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED| NOT REPORTED