MAUDE Adverse Event Report: RIFTON EQUIPMENT PACER GAIT TRAINER

Model Number K640

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

The evaluation could not be completed because the device involved in the incident was not returned to rifton.

Event Description

It was reported that the user was walking in the gait trainer when one of the bolts securing the upper frame broke allowing the upper frame to pivot downward around the remaining bolt.The user was supported by two aides, who transferred him to a wheelchair.The user was unhurt.

• 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: 9924361
• MDR Text Key: 195886916
• Report Number: 1319061-2020-00003
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: K640
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2016
• 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 Age: 18 YR
• Patient Weight: 59