BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 4304446 · Received November 24, 2014

    Report

    Report Number
    3002807715-2014-00036
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    May 1, 2014
    Report Date
    October 31, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. THE DEVICE HAS NOT BEEN EVALUATED YET. HOWEVER, A SERVICE ENGINEER WOULD CONDUCT AN ON-SITE EVALUATION 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 BRUISE. THE CUSTOMER ALSO MENTIONED THAT THE EVENT OCCURRED SIX MONTHS BACK. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED FOR THE INJURY. IF ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED AT A LATER DATE AFTER THE EVALUATION, 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 THE 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 HEAD. DOCTOR COMPLAINED OF SMALL INJURY DUE TO THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761854 RT-5100 REFRACTOR HKN NIDEK CO, LTD. RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK