MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. PRO 28Z CHAIR COT

Model Number	0012826
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a patient transport the medic crew attempted to convert the stretcher from the chair position to the bed position to prepare for loading into the ambulance; however, the handle utilized for the conversion would not function.The transport was delayed as another ambulance and stretcher need to be called to continue the patient transport.There were no reports of injury or adverse effects as a result of the delayed transport.
Event or Problem Description
It was reported that during a patient transport the medic crew attempted to convert the stretcher from the chair position to the bed position to prepare for loading into the ambulance; however, the handle utilized for the conversion would not function.The transport was delayed as another ambulance and stretcher need to be called to continue the patient transport.There were no reports of injury or adverse effects as a result of the delayed transport.
Additional Manufacturer Narrative
Through communications with the end user, the reported issue was confirmed and the appropriate replacements parts were identified and shipped to the customer for repair.The customer has confirmed the repair was completed and the stretcher is now functioning as intended.

• Brand Name: PRO 28Z CHAIR COT
• Common Device Name: PRO 28Z CHAIR COT
• 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: 20594638
• Report Number: 1523574-2024-00077
• Device Sequence Number: 17781542
• Product Code: FPO
• UDI-Device Identifier: 00190790002671
• UDI-Public: (01)00190790002671(11)230331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0012826
• Device Catalogue Number: 0012826
• Device Lot Number: M540150
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/02/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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