CHATTANOOGA INTELECT SHORTWARE 1600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-05-09 for CHATTANOOGA INTELECT SHORTWARE 1600 manufactured by Djo, Llc.

Event Text Entries

[16434563] Complaint received stating "the unit had become very hot under the monode and was sparking along with the smell of smoke. " product to be sent for review, but not yet received and/or reviewed. No pt involvement, no injury or impairment from this event. Without product review we are unable to confirm or deny if recurrence of the event would cause or contribute to a death or serious injury at this point.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2013-00007
MDR Report Key3114078
Report Source99
Date Received2013-05-09
Date of Report2013-05-09
Date of Event2013-04-12
Device Manufacturer Date2011-12-01
Date Added to Maude2013-07-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street1430 DECISION ST.
Manufacturer CityVISTA CA 92081
Manufacturer CountryUS
Manufacturer Postal92081
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Manufacturer StreetCARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
Manufacturer CityTIJUANA 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCHATTANOOGA INTELECT SHORTWARE
Generic NameINTELECT SHORTWAVE
Product CodeIMJ
Date Received2013-05-09
Model Number1600
Lot NumberT1379
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION ST VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-09

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