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

Model Number	0731403
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged while transporting a patient on the stair chair, one of the transport wheels detached from the chair.No injuries were reported as a result; however, a back up unit needed to be called to continue the transport.
Event or Problem Description
It was alleged while transporting a patient on the stair chair, one of the transport wheels detached from the chair.No injuries were reported as a result; however, a back up unit needed to be called to continue the transport.
Additional Manufacturer Narrative
A visual and functional evaluation was conducted on the subject chair at the customer location.The contributing factor was found to be stripped threading on the hardware.A new wheel was installed on the chair and it was returned to service.There was no additional information provided alleging the incident resulted in any adverse effect to the patient.

• 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: 18818696
• Report Number: 1523574-2024-00015
• Device Sequence Number: 18210605
• Product Code: FPO
• UDI-Device Identifier: 00190790004064
• UDI-Public: (01)00190790004064(11)230809
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: 0731403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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
• Patient Sex: Unknown