BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 4304448 · Received November 24, 2014

    Report

    Report Number
    3002807715-2014-00038
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Report Date
    July 7, 2014
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HKN
    Removal / Correction Number
    Z-1853-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVAL. THE DEVICE HAS NOT BEEN EVALUATED YET; HOWEVER, A SERVICE ENGINEER WOULD CONDUCT AN ON-SITE EVAL AND PERFORM THE PREVENTIVE MAINTENANCE ACCORDING TO THE RECALL PROCEDURE. NIDEK CONTACTED THE CUSTOMER TO VERIFY THE COMPLAINT ABOUT THE INJURY AND CONFIRMED THAT THE INJURY WAS MINOR. IT WAS A SMALL CUT. NO MED OR SURGICAL INTERVENTION WAS REQUIRED FOR THE INJURY. IF ADDITIONAL SIGNIFICANT INFO IS RECEIVED AT A LATER DATE AFTER THE EVAL, A FOLLOW UP REPORT WILL BE SUBMITTED. NIDEK INC CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    NIDEK RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2014. CUSTOMER REPORTED THAT DURING THE USE OF RT 5100 SN (B)(4), THE NEAR POINT CHART ARM FELL DOWN. THE NEAR POINT CHART ARM HIT THE DOCTOR ON THE FACE. DR COMPLAINED OF SMALL CUT ON THE NOSE DUE TO THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762139 RT-5100 REFRACTOR HKN NIDEK CO., LTD. RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK