MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. TRANSCEND STAIR CHAIR W/POWERTRAXX

Model Number	0731403
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	12/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while transporting a 450 lb patient down an exterior wooden staircase, the chair lost traction and slipped causing the medic crew to use additional force to avoid losing control of the chair.The patient was not injured; however, a medic did allege an injury described as a back sprain and required time off work.It was reported an attempt to remove a thin layer of snow from the stairs prior to transport was made and the temperature was approximately -3 deg celsius.
Additional Manufacturer Narrative
An authorized field technician conducted a visual and functional evaluation of the stair chair and could not find anything wrong with the chair and the reported issue could not be duplicated.The reported weather and surface conditions are being attributed to the root cause of the reported incident.
Event or Problem Description
It was reported while transporting a 450 lb patient down an exterior wooden staircase, the chair lost traction and slipped causing the medic crew to use additional force to avoid losing control of the chair.The patient was not injured; however, a medic did allege an injury described as a back sprain and required time off work.It was reported an attempt to remove a thin layer of snow from the stairs prior to transport was made and the temperature was approximately -3 deg celsius.

• Brand Name: TRANSCEND STAIR CHAIR W/POWERTRAXX
• Common Device Name: TRANSCEND STAIR CHAIR W/POWERTRAXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 wiel way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 19215632
• Report Number: 1523574-2024-00021
• Device Sequence Number: 20882495
• Product Code: FPO
• UDI-Device Identifier: 00190790004064
• UDI-Public: (01)00190790004064(11)230222
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 0731403
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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: Unknown
• Patient Weight: 204 KG