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

Model Number	0731403
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An authorized field technician was dispatched to conduct a visual and functional evaluation of the stair chair.The reported issue was confirmed and the chair was repaired with a replacement wheel.No further information has been provided regarding the patient's alleged injury.
Event or Problem Description
It was reported that while transporting a patient on the stair chair, the front right wheel detached from the chair resulting in the chair tipping forward and contacting the ground.The patient remained restained to the chair but her knees impacted the ground and she expressed pain in her knees.The patient was removed from the chair and assisted to the stretcher for transport to the medical facility.It is unknown if medical intervention was required for the alleged knee pain.The stair chair was removed from service pending evaluation.

• Brand Name: TRANSCEND STAIR CHAIR W/PWRTRX
• Common Device Name: TRANSCEND STAIR CHAIR W/PWRTRX
• 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: 20759608
• Report Number: 1523574-2024-00081
• Device Sequence Number: 8587292
• Product Code: FPO
• UDI-Device Identifier: 00190790004064
• UDI-Public: (01)00190790004064(11)230613
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Device Catalogue Number: 0731403
• Device Lot Number: M599520
• 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: 11/04/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 113 KG