MAUDE Adverse Event Report: DJO GLOBAL CHATTANOOGA; INTELECT TRANSPORT 2 CHANNEL

Model Number 2783

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

A (b)(6) pt 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 pt's shoulder.The device was turned off and a red mark was noted on the shoulder.No skin blistering noted, soft tissue message and ice application to affected area provided relief.No adverse effect was ever reported and the pt subsequently returned for add'l therapy.Complete inspection of the device was done by the facility bio-med department and they reportedly were unable to replicate the event.It was then sent to the mfr and they reportedly were unable to replicate but replaced the keypad.

• Brand Name: CHATTANOOGA
• Type of Device: INTELECT TRANSPORT 2 CHANNEL
• Manufacturer (Section D): DJO GLOBAL; 1430 decision street; vista CA 92081
• MDR Report Key: 4546567
• MDR Text Key: 5518090
• Report Number: MW5040903
• Device Sequence Number: 1
• Product Code: IMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2783
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR