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

Model Number	0015790
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while unloading a patient from the ambulance the "wheel tray" of the stretcher allegedly did not lock into position and the stretcher lowered to lowest position.No injury to the patient was reported but a medic alleged injury in the nature of back pain and sought medical evaluation.No information on the outcome of the evaluation was provided.
Additional Manufacturer Narrative
A visual and functional evaluation was conducted on the subject stretcher by an authorized field technician at the customer's location.The stretcher was found to be operating as intended and the reported issue could not be duplicated.No additional information was provided regarding the alleged injury.
Event or Problem Description
It was reported while unloading a patient from the ambulance the "wheel tray" of the stretcher allegedly did not lock into position and the stretcher lowered to lowest position.No injury to the patient was reported but a medic alleged injury in the nature of back pain and sought medical evaluation.No information on the outcome of the evaluation was provided.

• Brand Name: 35-XST PROFLEXX ST
• Common Device Name: 35-XST PROFLEXX ST
• 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: 17840036
• Report Number: 1523574-2020-00037
• Device Sequence Number: 7457052
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: (01)00190790000585(11)181108
• 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): 01/01/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• 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 Age: 37 YR
• Patient Sex: Female
• Patient Weight: 73 KG