MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35X-ST PROFLEXX

Model Number	0015790
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged while unloading a patient from the ambulance, the foot end medic was unaware the student assistant released the stretcher from the safety bail and the stretcher rolled off the ambulance deck and lowered to the ground.There was no report of injury to the patient or the medics.
Additional Manufacturer Narrative
An authorized field technician was dispatched to conduct a visual and functional evaluation at the customer location.There were no observations of product issues that would have contributed to the reported incident and the stretcher was operating as intended.The contributing factor of the incident is attributed to unintended use error.
Event or Problem Description
It was alleged while unloading a patient from the ambulance, the foot end medic was unaware the student assistant released the stretcher from the safety bail and the stretcher rolled off the ambulance deck and lowered to the ground.There was no report of injury to the patient or the medics.

• Brand Name: 35X-ST PROFLEXX
• Common Device Name: 35X-ST PROFLEXX
• 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: 18222462
• Report Number: 1523574-2023-00041
• Device Sequence Number: 14870811
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: (01)00190790000585(11)180326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/02/2024

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: 0015790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2018
• 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
• Patient Sex: Male
• Patient Weight: 91 KG