MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35X PROFLEXX AMBULANCE COT

Model Number	0015690
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance at the hospital, the legs of the cot allegedly would not disengage.The patient was removed from the cot and walked inside the hospital.There were no reports of injury or adverse effect to the patient or crew as a result of the incident.
Additional Manufacturer Narrative
An authorized field technician was dispatched to evaluate the cot at the complainant's location.A visual and functional evaluation was conducted and it was determined the cot was operating within specification; however, the set load height of the cot was lower than the load height of the ambulance it was being used in.The technician reset the load height of the cot to the highest position.The technician also found the axle bolts were extremely tight and loosened those as well.The cot was returned to service.The complainant advised the patient was in a stable condition and the incident did not hinder medical treatment or create further injury to the patient.Instructions are provided in the ifu on how to increase the load height of the cot in relation to the ambulance it is being used in.
Event or Problem Description
It was reported while unloading a patient from the ambulance at the hospital, the legs of the cot allegedly would not disengage.The patient was removed from the cot and walked inside the hospital.There were no reports of injury or adverse effect to the patient or crew as a result of the incident.

• Brand Name: 35X PROFLEXX AMBULANCE COT
• Common Device Name: 35X PROFLEXX AMBULANCE COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 7503403
• Report Number: 1523574-2018-00019
• Device Sequence Number: 16648680
• Product Code: FPO
• UDI-Device Identifier: 00190790000295
• UDI-Public: 00190790000295
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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: Emergency Medical Technician
• Device Model Number: 0015690
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 127