BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17770545 · Received September 18, 2023

    Report

    Report Number
    9610877-2023-58969
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 19, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE LENS CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE OBJECTIVE LENS. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE INSERTION FLEXIBLE TUBE COATING DAMAGE, THE LIGHT GUIDE CABLE COMPRESSED (SHORT IN LENGTH), THE LIGHT GUIDE CABLE BUCKLED, THE LG PRONG DEFORMED, THE OPERATION CHANNEL (PRIMARY) LEAK, THE REMOTE CONTROL BUTTONS CUT, THE SEGMENT HARD TO MOVE, AND THE ADJUSTING COLLAR RUPTURE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586(IMAGE FAILURE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    ON JUN 29, 2022, AT 5:02 PM, (B)(4) WROTE: DAN, PLEASE SEE THE ATTACHED LOGS THAT DAVE HAD ME DOWNLOAD ON A GRAY T1 THAT BELONGS TO UPMC STATMEDEVAC. THEY ARE CONCERNED THAT THEY ARE HAVING ISSUES WITH THE "GRAY VERSION" VS THE "RED VERSION". THEY HAVE 40 PLUS RED ONES AND 5 GRAY T1S. THIS DEVICE HAD A "SAFETY VALVE " CONDITION AND WHITE SCREEN ON A PATIENT DURING A TRANSPORT. NO ADVERSE PATIENT REACTIONS, BUT LOTS OF CONCERNS. CAN THIS BE REPAIRED IN THE FIELD ? THEY SHARED THIS DOCUMENT TO SHOW THE OTHER DEVICES. WE SHOULD HAVE RGA ON THE UNITS BELOW. HAMILTON GRAY T1 VENTILATOR 509476 2/23/2021 REPAIR TECHNICAL EVENT 232035 WHILE HFNC (B)(4) PENDING RMA HAVE A GREAT DAY! KIND REGARDS, JOE JOSEPH MANES RRT-NPS,CPFT, RCP ACCOUNT MANAGER HAMILTON MEDICAL, INC. 4655 AIRCENTER CIRCLE RENO, NV 89502 UNITED STATES PHONE: (800) 426 6331, EXT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097689 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown