MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35 XST PROFLEXX

Model Number	0015790
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleges that while loading a patient into the truck, the disc/pud at the headend came off in which the cot then lowered to the ground.Patient alleges injury to the neck, medic alleges injury to the back and emt alleges injury to the hip.No further details in regards to injuries sustained or additional medical intervention have been provided.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician.A visual evaluation of the cot confirmed the reported issue.The cot was repaired, function tested and returned to service.It could not be determined what caused the component to come off or if the component became loose over time.The cot remains functional without the subject component and the reported failure is not related to the missing component.Sufficient instructions are contained in the ifu for maintaining control of the cot and verifying the position of the cot prior to pulling it from the ambulance.Instruction is also provided for inspecting the cot for normal wear and tear and any loose hardware.There has been no further information provided regarding the alleged injuries or any required medical intervention.
Event or Problem Description
Complainant alleges that while loading a patient into the truck, the disc/pud at the headend came off in which the cot then lowered to the ground.Patient alleges injury to the neck, medic alleges injury to the back and emt alleges injury to the hip.No further details in regards to injuries sustained or additional medical intervention have been provided.

• Brand Name: 35 XST PROFLEXX
• Common Device Name: 35 XST PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6772393
• Report Number: 1523574-2017-00030
• Device Sequence Number: 18869467
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: 00190790000585
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/05/2017

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: 0015790
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other