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

Model Number	0015710
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the stretcher allegedly failed to engage with the ambulance safety hook and the patient fell off the stretcher resulting in an abrasion to their head and left arm.The patient was transported to the er for further evaluation.No further details of the incident were provided.
Event or Problem Description
It was reported the stretcher allegedly failed to engage with the ambulance safety hook and the patient fell off the stretcher resulting in an abrasion to their head and left arm.The patient was transported to the er for further evaluation.No further details of the incident were provided.
Additional Manufacturer Narrative
An authorized field technician was dispatched to conduct a visual and functional evaluation at the customer's location.The stretcher was cycle tested and the reported issue could not be duplicated.All hardware and spings in the safety bail assembly were present, tight and functioning as intended.No repairs were required and the stretcher was returned to service.

• Brand Name: 35X PROFLEXX
• Common Device Name: 35X 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: 20976590
• Report Number: 1523574-2024-00085
• Device Sequence Number: 19841975
• Product Code: FPO
• UDI-Device Identifier: 00190790000332
• UDI-Public: (01)00190790000332(11)181030
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/03/2025

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: 0015710
• Device Catalogue Number: 0015710
• Device Lot Number: M024790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female