RT-5100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-24 for RT-5100 manufactured by Nidek Co., Ltd..

Event Text Entries

[5273363] 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.
Patient Sequence No: 1, Text Type: D, B5


[12714078] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002807715-2014-00035
MDR Report Key4304459
Report Source05,06
Date Received2014-11-24
Date of Report2014-10-29
Date of Event2014-07-11
Date Mfgr Received2014-10-29
Device Manufacturer Date2008-07-01
Date Added to Maude2014-12-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNEO YAMAGUCHI
Manufacturer Street47651 WESTINGHOUSE DRIVE
Manufacturer CityFREMONT CA 94539
Manufacturer CountryUS
Manufacturer Postal94539
Manufacturer Phone5103537785
Manufacturer G1NIDEK CO., LTD.
Manufacturer Street34-14 HIROISHI
Manufacturer CityGAMAGORI, AICHI
Manufacturer CountryJA
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-1853-2014
Event Type3
Type of Report3

Device Details

Brand NameRT-5100
Generic NameREFRACTOR
Product CodeHKN
Date Received2014-11-24
Model NumberRT-5100
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNIDEK CO., LTD.
Manufacturer Address34-14 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-24

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