MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; TRITON DTS

Catalog Number 2841

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

An mdr reportable event.Complaint rec'd from clinician that alleges "pt was receiving tractione treatment - pt rang call bell.Unit had not stopped pulling abd pts head was out of traction." questionnaire not rec'd from clinician and/or pt.No injury reported, therefore no medical treatment at time of incident or after reported.Product not returned to mfr for review.No indication event caused or contributed to permanent impairment, serious injury or death.

• Brand Name: CHATTANOOGA
• Type of Device: TRITON DTS
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A., C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana 2224 4; MX 22244
• Manufacturer Contact: 1430 decision street; vista, CA 92081 ; 7607271280
• MDR Report Key: 3810909
• MDR Text Key: 4384199
• Report Number: 9616086-2014-00008
• Device Sequence Number: 1
• Product Code: ITH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2841
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1