MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. MODEL 28

Model Number	0012801
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An incident occurring in thailand on a 2022 model 28 stretcher was reported by a distributor representative.Per the end user a heavy patient was loaded into the ambulance and because the were having trouble breathing in the bed position while in the ambulance, the ems personnel adjusted the backrest of the stretcher to an upright position.The stretcher was then unloaded from the ambulance before returning the backrest to the fully reclined position and as the wheels touched the ground a screw in the backrest allegedly came loose and broke.The patient remained in a semi-reclining position on the stretcher and no injuries were associated; however, the ems crew call for an additional crew and stretcher to assist with continuing the patient transport, which resulted in a delay.No adverse effects have been reported as a result of the delay in transport.Pictures of the alleged issue were provided for review.Observations of rust on existing hardware were made which could result in weakness of the structural integrity of the hardware and may have contributed to the alleged bolt breaking.Replacement parts were provided to the distributor for repair of their customer's stretcher.

• Brand Name: MODEL 28
• Common Device Name: MODEL 28
• 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: 23979701
• Report Number: 1523574-2026-00015
• Device Sequence Number: 4554239
• Product Code: FPO
• UDI-Device Identifier: 00190790000097
• UDI-Public: (01)00190790000097(11)220809
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: 0012801
• Device Catalogue Number: 0012801
• Device Lot Number: M367980
• 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: 12/08/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2022
• 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: Male
• Patient Weight: 130 KG