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

Model Number	0015790
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleges while unloading the patient from the ambulance, the stretcher legs allegedly did not lower.The stretcher then rotated to the right and landed on its side.The patient reported alleged pain to the right flank.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician at the complainants site.A visual and functional evaluation was conducted.The technician found the stretcher to be in proper working order and was unable to find any issues that would have contributed to the legs not lowering.The ifu provides clear instruction for maintaining control fo the device at all times.No further details were provided pertaining to the alleged patient injury or if any further intervention was sought.
Event or Problem Description
Complainant alleges while unloading the patient from the ambulance, the stretcher legs allegedly did not lower.The stretcher then rotated to the right and landed on its side.The patient reported alleged pain to the right flank.

• 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: 8366547
• Report Number: 1523574-2019-00009
• Device Sequence Number: 16541120
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: 00190790000585
• 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): 04/02/2019

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: 02/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/03/2019
• 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 Age: 80 YR
• Patient Weight: 77