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

Model Number	015710
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant alleges while unloading the cot from the ambulance, the cot legs allegedly failed to lower.The stretcher tilted to the side resulting in an alleged injury to a medic.No details were provided pertaining to the nature of the injury or medical intervention sought.
Additional Manufacturer Narrative
A visual and functional evaluation was conducted on the subject cot and the reported issue was not able to be duplicated.No malfunctions were observed and the cot was operating according to specification.The ifu for the product provides sufficient instructions on maintaining control of the cot while unloading the cot from the truck.The complainant has not provided any further details regarding the alleged medic injury or medical intervention sought.
Event or Problem Description
The complainant alleges while unloading the cot from the ambulance, the cot legs allegedly failed to lower.The stretcher tilted to the side resulting in an alleged injury to a medic.No details were provided pertaining to the nature of the injury or medical intervention sought.

• Brand Name: 35-X PROFLEXX-EFNY
• Common Device Name: 35-X PROFLEXX-EFNY
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh
• MDR Report Key: 9869189
• Report Number: 1523574-2020-00008
• Device Sequence Number: 16904219
• Product Code: FPO
• UDI-Device Identifier: 00190790000332
• UDI-Public: 00190790000332
• Combination Product (Y/N): N
• 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): 06/02/2020

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: 015710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 06/02/2020
• 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 Age: 70 YR