MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON GAIT TRAINER

Model Number K503

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

To date the reporter has not provided any additional information about the user.The device is around 17 years old, and the casters had been previously replaced by the customer.It is likely that the caster would have been loose and wobbly for some time before it detached from the frame.In the product manual we instruct users to: inspect this product and accessories regularly for loose or missing screws, metal fatigue, cracks, broken welds, missing attachments, general instability or other signs of excessive wear.Immediately remove this product from use when any condition develops that might make operation unsafe.Replace or repair components or products that are damaged or appear to be unstable.

Event Description

It was reported that one of the front casters of the rifton gait trainer came off while the user was going over a threshold.The user tipped sideways and fell into the door frame, receiving a cut on his face.

Manufacturer Narrative

According to the reporter, the device user is 10 lbs over the 200 lb weight limit of the device.In addition, the device is around 17 years old, and the casters had been previously replaced by the customer.It is likely that the caster would have been loose and wobbly for some time before it detached from the frame.In the product manual we instruct users to: inspect this product and accessories regularly for loose or missing screws, metal fatigue, cracks, broken welds, missing attachments, general instability or other signs of excessive wear immediately remove this product from use when any condition develops that might make operation unsafe.Replace or repair components or products that are damaged or appear to be unstable.

• Brand Name: RIFTON GAIT TRAINER
• Type of Device: GAIT TRAINER
• Manufacturer (Section D): RIFTON EQUIPMENT; 103 woodcrest drive; rifton NY 12471
• MDR Report Key: 11429487
• MDR Text Key: 238414349
• Report Number: 1319061-2021-00004
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: K503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 95