MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWER X1

Model Number	0015807
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user reported while unloading a patient from the ambulance the head end wheels of the stretcher caught the ambulance bumper and the stretcher twisted to the patient right and fell to the ground.The patient remained restrained to the stretcher but did sustain a small laceration to the elbow.The patient was evaluated and discharged from the er.There was not injury to the medics.The end user is an authorized field technician and advised that they conducted an evaluation and preventive maintenance on the stretcher.There was no allegation of a product malfunction contributing to the reported incident.

• Brand Name: POWER X1
• Common Device Name: POWER X1
• 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: 24159330
• Report Number: 1523574-2026-00006
• Device Sequence Number: 18420028
• Product Code: FPO
• UDI-Device Identifier: 00190790002183
• UDI-Public: (01)00190790002183(11)210406
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/22/2026

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: 0015807
• Device Catalogue Number: 0015807
• Device Lot Number: M945930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2021
• 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: 181 KG