MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. TRANSCEND W/PWRTRAX

Model Number	0731405
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while transporting a patient down stairs, the piston on the track assembly broke away from the chair resulting in unintended movement of the track assembly and the attending medics had to suddenly catch the chair to control its movement.There were no injuries to the patient; however, both medics alleged muscle strain to their back and one medic also alleged shoulder strain.Neither medic sought medical intervention but rather required rest folowing the incident.The end user advised they have reported this incident on a medsun report.The customer provided images of the chair and the alleged issue was able to be confirmed.Replacement parts were provided to the end user as they are an authorized field technician.The end user confirmed the chair has been repaired and returned to service.The replaced gas spring has been returned to the manufacturer for further analysis.

• Brand Name: TRANSCEND W/PWRTRAX
• Common Device Name: TRANSCEND W/PWRTRAX
• 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: 24247184
• Report Number: 1523574-2026-00016
• Device Sequence Number: 8326527
• Product Code: FPO
• UDI-Device Identifier: 00190790006334
• UDI-Public: (01)00190790006334(11)250702
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/03/2026

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: 0731405
• Device Catalogue Number: 0731405
• Device Lot Number: M119370
• 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: 01/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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: Unknown
• Patient Weight: 136 KG