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

Model Number	0015790
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while unloading a patient from the ambulance the latch was pressed too early before the legs were down causing the stretcher to fall with the patient.The patient remained restrained to the stretcher, but allegedly did complain of right elbow pain as a result.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician at the customer's location on 10/17/2019.A visual and functional evaluation was conducted.The cot functioned as intended, with no malfunctions.The ifu contains sufficient instructions for proper unloading of the stretcher from the ambulance the cot was returned to service.
Event or Problem Description
It was reported while unloading a patient from the ambulance the latch was pressed too early before the legs were down causing the stretcher to fall with the patient.The patient remained restrained to the stretcher, but allegedly did complain of right elbow pain as a result.

• 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: 9168165
• Report Number: 1523574-2019-00033
• Device Sequence Number: 305496
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: 0190790000585
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 0015790
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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
• Patient Weight: 91