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

Model Number	0012826
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported while unloading a patient from the ambulance it was noticed the legs would not lock out.Upon further inspection it was found the leg had broken at the wheel casting.There were no injuries to the patient or the medic crew as a result ; however, the patient did need to be assisted to a backup stretcher to continue the transport.
Additional Manufacturer Narrative
A visual and functional evaluation was conducted by an authorized field technician at the customer's location.The alleged broken leg assembly was confirmed, repaired and the stretcher was returned to service.
Event or Problem Description
The end user reported while unloading a patient from the ambulance it was noticed the legs would not lock out.Upon further inspection it was found the leg had broken at the wheel casting.There were no injuries to the patient or the medic crew as a result; however, the patient did need to be assisted to a backup stretcher to continue the transport.

• 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: 18580579
• Report Number: 1523574-2024-00006
• Device Sequence Number: 20955197
• 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): 05/22/2024

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: 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: 01/16/2024
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 05/22/2024
• 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