MAUDE Adverse Event Report: RIFTON EQUIPMENT PACER GAIT TRAINER

Model Number K640

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tooth Fracture (2428)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

The reporter indicated that the device was being used in the reverse position.Pictures of the device setup sent by the reporter show the accessories positioned near the end of the accessory mounting rails.This positioning would result in the user's center of gravity being near the outside edge of the frame.The product manual warns: "position accessories so that the client's weight is centered between the casters." "to prevent tipping and resulting injury, do not position handloops, arm prompts or arm platforms at the extreme ends of the top bar.".

Event Description

It was reported that while walking in the gait trainer the user tipped the forward and broke two teeth.

• Brand Name: PACER GAIT TRAINER
• Type of Device: GAIT TRAINER
• Manufacturer (Section D): RIFTON EQUIPMENT; 103 woodcrest drive; rifton NY 12471
• Manufacturer (Section G): RIFTON EQUIPMENT; 103 woodcrest drive; rifton NY 12471
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 10588654
• MDR Text Key: 208628267
• Report Number: 1319061-2020-00005
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: K640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention