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 while conducting an emergency transfer the lower leg casting on the stretcher broke.The patient was transferred to another stretcher to complete the transport and no injury or adverse effects were reported as a result of the issue.
Additional Manufacturer Narrative
An authorized field technician was dispatched to the customer's location to conduct a visual and functional evaluation of the subject stretcher.The reported issue was confirmed and the leg assembly was replaced and the stretcher was returned to service.
Event or Problem Description
It was reported while conducting an emergency transfer the lower leg casting on the stretcher broke.The patient was transferred to another stretcher to complete the transport and no injury or adverse effects were reported as a result of the issue.

• 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: 19811432
• Report Number: 1523574-2024-00054
• Device Sequence Number: 12636621
• Product Code: FPO
• UDI-Device Identifier: 00190790002671
• UDI-Public: (01)00190790002671(11)230321
• 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): 08/05/2024

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
• 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: 06/29/2024
• Supplement Date Received by Manufacturer: 06/29/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: Unknown