MAUDE Adverse Event Report: DJO, LLC TRITON DTS PKG US STD; EQUIPMENT, TRACTION, POWERED

Model Number	2841
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.A follow-up report will be submitted upon completion thereof.
Event or Problem Description
It was reported that the traction device powered off and turned on again during treatment.It then suddenly pulled on the patient's neck.There was reportedly no patient injury.

• Brand Name: TRITON DTS PKG US STD
• Common Device Name: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8288448
• Report Number: 9616086-2019-00005
• Device Sequence Number: 19321013
• Product Code: ITH
• UDI-Device Identifier: 00888912022170
• UDI-Public: 00888912022170
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K053223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1