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

Model Number	0015790
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges while loading a patient into the ambulance the drop frame allegedly bent when the foot end of the cot was lifted.The operators then chose to have the patient transferred to another stretcher to complete the transfer.No injuries or delay in treatment were reported as a result of the incident.
Event or Problem Description
Complainant alleges while loading a patient into the ambulance the drop frame allegedly bent when the foot end of the cot was lifted.The operators then chose to have the patient transferred to another stretcher to complete the transfer.No injuries or delay in treatment were reported as a result of the incident.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician at the complainants site.A visual and functional evaluation wasconducted.The technician found the stretcher to be in proper working order however; the technician found the customer had incorrectly insalled the straps of an accessory to the drop frame.This allowed the drop frame to bend when pressure was applied to the accessory.The ifu provides clear instruction for the proper installation of the accessory.

• 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: 8721964
• Report Number: 1523574-2019-00021
• Device Sequence Number: 16576494
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: 00190790000585
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/28/2019

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: 06/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: 64