I-CAT 0.830.4000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-07-02 for I-CAT 0.830.4000 manufactured by Imaging Sciences International, Llc.

Event Text Entries

[20736872] On (b)(6) 2012, while discussing a similar issue (see mdr (b)(6)), the dealer stated that he had heard that an "out of memory" error and reversed ct image failure had occurred at this location.
Patient Sequence No: 1, Text Type: D, B5


[20904970] The dealer provided the serial number and address and contact info. Actual circumstances and details of the event are not yet known; we are investigating. The reported failure is similar to the issue reported in mdr 2530069-2012-00011. Investigation is underway.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2530069-2012-00013
MDR Report Key2645166
Report Source08
Date Received2012-07-02
Date of Report2012-06-29
Date of Event2012-06-04
Date Mfgr Received2012-06-04
Device Manufacturer Date2010-12-08
Date Added to Maude2012-10-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactELIZABETH LAZARO
Manufacturer Street1910 NORTH PENN RD.
Manufacturer CityHATFIELD PA 19440
Manufacturer CountryUS
Manufacturer Postal19440
Manufacturer Phone2679540365
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameI-CAT
Generic NameSYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL
Product CodeMUH
Date Received2012-07-02
Catalog Number0.830.4000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerIMAGING SCIENCES INTERNATIONAL, LLC
Manufacturer Address1910 NORTH PENN RD. HATFIELD PA 19440 US 19440


Patients

Patient NumberTreatmentOutcomeDate
10 2012-07-02

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