MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. MODEL 42 STAIR CHAIR

Model Number 0714868

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Fall (1848); Laceration(s) (1946); Injury (2348)

Event Date 02/18/2016

Event Type  Injury  

Event Description

On (b)(6) 2016 ferno was made aware of an incident that occurred on (b)(6) 2016 wherein the subject stair chair was being used to transport a patient, approximately (b)(6) lbs, from their home to an ambulance cot awaiting outside the home.As the chair was being moved down 3 concrete stairs it is alleged the handles at the back of the chair broke.The patient fell backwards onto the assisting firefighter.It is alleged the firefighter was injured but no specific information has been provided at this time about his injury.It was reported the patient denied pain or injury except for a laceration on their upper arm.An investigation has been initiated to gather additional information about the incident and the alleged malfunction.

Manufacturer Narrative

The device in question was not made available for evaluation due to pending insurance claims; however, pictures of the device and an incident were provided.In review of the pictures the alleged malfunction could be confirmed; however, requests for additional information pertaining to the use of the device during the incident and the maintenance of the device were unanswered.Upon review of the pictures and the provided information it was observed the bolt on the left handle of the chair did appear to be loose which could potentially cause an uneven distribution of force on the handles of the chair.The bolt on the right handle appeared to be tight.Existing stress marks on the device were unable to be seen in the pictures.It was confirmed with the approved service company there were no prior service records for this device nor was there an active contract in place for preventative maintenance.Historical records were reviewed for any other related incidents and it was determined this report represented an isolated issue.Additional communication with both the transport service and the fire service revealed the medic crew was attending to a 2nd patient and taking a report while the fire crew was attending to the patient involved in this incident as well as operating the chair.The chair belonged to the transport service; however, and the fire crew was not trained on the proper operation of the chair.A representative from the fire service did state the chair was being carried throughout the transport.Inquiry was made if any sudden movements occurred which could have potentially created stress on the handles with the heavy patient.This information was not known.The fire service confirmed the alleged injury consisted of a knee injury and laceration to the right leg.The firefighter was seen at the er and returned to work on light duty while continuing treatment of the knee injury.No additional information was provided on alleged injury to the patient.Only pictures were provided.

Event Description

On (b)(6) 2016 ferno was made aware of an incident that occurred on (b)(6) 2016 wherein the subject stair chair was being used to transport a patient, approximately (b)(6), from their home to an ambulance cot awaiting outside the home.As the chair was being moved down 3 concrete stairs it is alleged the handles at the back of the chair broke.The patient fell backwards onto the assisting firefighter.It is alleged the firefighter was injured but no specific information has been provided at this time about his injury.It was reported the patient denied pain or injury except for a laceration on their upper arm.An investigation has been initiated to gather additional information about the incident and the alleged malfunction.

• Brand Name: MODEL 42 STAIR CHAIR
• Type of Device: MODEL 42 STAIR CHAIR
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 5529693
• MDR Text Key: 41312130
• Report Number: 1523574-2016-00010
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

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: Service Personnel
• Device Model Number: 0714868
• Device Catalogue Number: PT4200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 03/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 132