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

Model Number	0015794
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
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 transporting a patient.The complainant has not provided any further details regarding the alleged patient injury or whether medical intervention was sought.
Event or Problem Description
The complainant reported while transporting a patient on the stretcher, the stretcher hit uneven pavement while rotating the stretcher and the unit then allegedly tipped over with the patient.The patient alleges a bruise to their left elbow however; no treatment was sought 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: 8632156
• Report Number: 1523574-2019-00018
• Device Sequence Number: 1655129
• Product Code: FPO
• UDI-Device Identifier: 00190790000387
• UDI-Public: 00190790000387
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 05/22/2019

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: 0015794
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: 113