MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. IN X, FOR INLINE

Model Number 0015803

Device Problems Self-Activation or Keying (1557); Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 04/03/2019

Event Type  Injury  

Event Description

The complainant alleges while unloading the patient from the ambulance the operator released the stretcher from the safety hook prior to confirming the legs were lowered and the wheels were on the ground.This allowed the stretcher to lower unexpectedly.The patient allegedly sustained a minor laceration to the right elbow.Details of medical intervention were not provided.

Manufacturer Narrative

A visual and functional evaluation was conducted by an authorized technician.The technician found the cot to be functioning as intended.There were no observations that would have contributed to the alleged incident.The alleged issue could not be duplicated.The ifu for the product provides sufficient instructions on proper unloading of the cot using both power and manual methods.No further patient details have been provided.

Event Description

The complaintant alleges while unloading the patient from the abulance the operator released the stretcher from the safety hook prior to confirming the legs were lowered and the wheels were on the ground.This allowed the stretcher to lower unexpectedly.The patient allegedly sustained a minor laceration to the right elbow.Details of medical intervention were not provided.

• Brand Name: IN X, FOR INLINE
• Type of Device: IN X, FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 8488094
• MDR Text Key: 141082846
• Report Number: 1523574-2019-00015
• Device Sequence Number: 1
• Product Code: FPO
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015803
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other