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

Model Number 2841

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 12/04/2018

Event Type  Injury  

Event Description

It was reported that at the end of the session, the unit pulled the rope hard and hurt a patient, who had to be moved to the emergency room (er).Thereafter, the unit was reportedly unwinding slowly without any pressure.The facility biomedical engineer reportedly performed a zero load cell procedure and it continues to unwind.Further information was requested regarding extent of injury.

Manufacturer Narrative

Additional information regarding the incident was provided.The patient was treated for neck pain.The rope was at a 30-degree angle with 20 lbs intermitted cervical attachment (20" on / 10" off x 10 minutes).After the patient was placed supine with lower extremities on a stool and head / neck in a cervical sled attachment, the rope release button was depressed to release tension prior to the start of treatment (prior to programming the machine).Rather than the rope tension releasing, the cord instead recoiled sharply and forcefully back into the unit, pulling upward.The operator's hand felt tension that could not be overcome.The patient also felt the pull and was startled.The operator briefly saw a red warning box but could not read it.Instead, the operator powered off the machine and removed the patient from the table.

Manufacturer Narrative

The device was returned for evaluation.The evaluation could not replicate the rope pulling too hard or feeding out on its own.The device passed all functional testing but would not return all the way to zero pounds; it went down to five pounds.This would not have contributed to the incident nor would it have been a safety risk as it still returned to the range where the rope could release.

• Brand Name: TRITON DTS PKG US STD
• Type of Device: EQUIPMENT, TRACTION, POWERED
• Manufacturer (Section D): DJO; 1430 decision street; vista CA 92081
• MDR Report Key: 8227573
• MDR Text Key: 132410059
• Report Number: 9616086-2019-00001
• Device Sequence Number: 1
• Product Code: ITH
• Combination Product (y/n): N
• PMA/PMN Number: K053223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2019
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 94