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

Model Number 0015790

Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2019

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 35-XST PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 8721964
• MDR Text Key: 149206176
• Report Number: 1523574-2019-00021
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00190790000585
• UDI-Public: 00190790000585
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 0015790
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 64