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

Model Number	0012826
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While on a call, the medic crew attempted to lower the stretcher to the lowest level to load the patient and the stretcher would not lower to the ground or transition into the chair position.No injuries or adverse consequences were reported; however, a back up stretcher was needed to complete the patient transport.
Event or Problem Description
While on a call, the medic crew attempted to lower the stretcher to the lowest level to load the patient and the stretcher would not lower to the ground or transition into the chair position.No injuries or adverse consequences were reported; however, a back up stretcher was needed to complete the patient transport.
Additional Manufacturer Narrative
An authorized service technician was dispatched to conduct a visual and functional evaluation at the customer's location.The reported issue was confirmed, the associated subassembly components were replaced and the stretcher was returned to service.

• 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: 21104394
• Report Number: 1523574-2024-00092
• Device Sequence Number: 9145888
• Product Code: FPO
• UDI-Device Identifier: 00190790002671
• UDI-Public: (01)00190790002671(11)210113(21F007304
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0012826
• Device Catalogue Number: 0012826
• Device Lot Number: M869600
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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: Unknown