DR-3DT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-04-25 for DR-3DT manufactured by .

Event Text Entries

[2111146] A recent dr-3dt software upgrade enabled automatic iscore printing at four locations around the country. The new feature produced some inaccurate iscore recommendation reports. This malfunction would likely contribute to serious eye injury if the malfunction were to recur without being detected. This error only occurred using the new automated iscore printing function. Iscore reports printed by the automated printing process, where a revision was made by the (b)(4), contained the original recommendation text instead of the revised recommendation. The query used by the automated iscore process used the "recommendation" data field from the analysis table instead of the "recommendation" data field from the evalsumaudit table in the dr-3dt database. No patients were injured. The software was fixed to preclude any recurrence of this error.
Patient Sequence No: 1, Text Type: D, B5


[9250687] Through examination of the software queries, inoveon confirmed the query used to obtain evaluation summary data referenced the original recommendation data table even when a revised recommendation was available in another table. Auto printing of iscore reports was suspended until a software modification was developed and tested. After successful validation tests were completed, the fix was implemented and auto print feature enabled.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1651093-2006-00045
MDR Report Key2166486
Report Source07
Date Received2006-04-25
Date Mfgr Received2006-03-08
Device Manufacturer Date2006-02-01
Date Added to Maude2011-07-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactDAVID CROUSER
Manufacturer Street800 NORTH RESEARCH PKWY. SUITE 370
Manufacturer CityOKLAHOMA CITY OK 731043698
Manufacturer CountryUS
Manufacturer Postal731043698
Manufacturer Phone4052718001
Single Use3
Remedial ActionMA
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDR-3DT
Generic NameNONE
Product CodeNFG
Date Received2006-04-25
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-04-25

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