BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 4304459 · Received November 24, 2014

    Report

    Report Number
    3002807715-2014-00035
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    July 11, 2014
    Report Date
    October 29, 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
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. THE NEAR POINT CHART ARM HAS BEEN FIXED. NIDEK CONTACTED THE CUSTOMER TO VERIFY THE COMPLAINT ABOUT THE CUT ON THE NOSE AND CONFIRMED THAT THE INJURY WAS MINOR. NO MED OR SURGICAL INTERVENTION WAS REQUIRED FOR THE INJURY. THE PROVIDER WHO GOT THE INJURY WAS FINE. 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 THE CUSTOMER ON (B)(6) 2014. DURING THE PREVENTIVE MAINTENANCE (PM) FOR RECALL FOR RT-5100 SN (B)(4), THE PROVIDER WHO WAS PERFORMED THE PM GOT HIT BY THE NEAR POINT CHART ARM. THE PROVIDER GOT A SMALL CUT ON THE NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762266 RT-5100 REFRACTOR HKN NIDEK CO., LTD. RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK