MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON TRAM; TRANSFER AND MOBILITY DEVICE

Model Number	K320
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter did not know how the incident happened, but it is possible that adjustment of the strap during the transfer caused it to loosen.After the incident, the reporter inspected the strap and buckle and could not find anything broken or defective.
Event or Problem Description
It was reported that the user was being transferred in a seated position using the tram transfer device.During the transfer, the user slipped through the body support and fell to the floor.The user was not injured.

• Brand Name: RIFTON TRAM
• Common Device Name: TRANSFER AND MOBILITY DEVICE
• 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: 20621150
• Report Number: 1319061-2024-00003
• Device Sequence Number: 18026129
• Product Code: FSA
• UDI-Device Identifier: 00858101008193
• UDI-Public: 00858101008193
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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 Model Number: K320
• Device Catalogue Number: K320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 91 KG