CHATTANOOGA 2783

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-11 for CHATTANOOGA 2783 manufactured by Djo Global.

Event Text Entries

[16183573] A (b)(6) patient ordered to receive e-stim therapy s/p shoulder impingement syndrome. During a second round of e-stim therapy, the medical device stopped working (setting of 20pps). Upon restarting the device, the setting button jumped from 15pps to 50pps causing pain to the patient's shoulder. The device was turned off and a red mark was noted on the shoulder. No skin blistering noted, soft tissue massage and ice application to affected area provided relief. No adverse effect was ever reported and the patient subsequently returned for additional therapy. Complete inspection of device was done by the facility bio-med department and they reportedly were unable to replicate the event. It was then sent to the manufacturer and they reportedly were unable to replicate the event but replaced the keypad.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5040775
MDR Report Key4528316
Date Received2015-02-11
Date of Report2015-02-10
Date of Event2014-11-03
Date Added to Maude2015-02-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCHATTANOOGA
Generic NameINTELECT TRANSPORT 2 CHANNEL
Product CodeGZI
Date Received2015-02-11
Returned To Mfg2014-11-14
Model Number2783
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerDJO GLOBAL
Manufacturer Address1430 DECISION STREET VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-11

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