MAUDE Adverse Event Report: FERNO TRANSCEND STAIR CHAIR

Model Number	0731401
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported while transporting a patient on the stair chair, down 7 steps, the black bar on the underside of the chair separated from the chair.There was no allegation of the chair collapsing or tipping; however, it was reported that the patient had to be lifted by sheet to complete the patient transport.No injuries to the patient or medic crew were reported as a result of the product issue.

• Brand Name: TRANSCEND STAIR CHAIR
• Common Device Name: TRANSCEND STAIR CHAIR
• Manufacturer (Section D): FERNO; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; +1(937)283-2900
• MDR Report Key: 50675728
• Report Number: 1523574-2026-00090
• Device Sequence Number: 18749321
• Product Code: FPP
• UDI-Device Identifier: 00190790004040
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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
• Operator of Device: Health Professional
• Device Model Number: 0731401
• Device Catalogue Number: 0731401
• Device Lot Number: M194400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 300 LB