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

Model Number 2841

Device Problem Unintended System Motion (1430)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.A follow-up report will be submitted upon completion thereof.

Event 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
• Type of Device: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brian becker ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8288448
• MDR Text Key: 134460331
• Report Number: 9616086-2019-00005
• Device Sequence Number: 1
• Product Code: ITH
• UDI-Device Identifier: 00888912022170
• UDI-Public: 00888912022170
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2018
• 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: Reuse
• Patient Sequence Number: 1