MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. MODEL 40 OS STAIR CHAIR

Model Number 0714851

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The product was received and evaluated by ferno.At the time of the reported incident the product was 13 years old.A visual evaluation confirmed the complaint of the handles breaking.There was evidence that both handles had bent prior to breaking and the left side shows evidence of cracking prior to breaking.Both breaks occurred at the location of the screw that attaches the handle to the chair frame.It was determined the issue was a result of the age of the device and years of use and stress.This malfunction is not deemed to be a reportable malfunction as instructions are provided for inspection and maintenance of the chair as needed to verify no damage or excessive wear.The initial complaint alleged pain from injuries from both emt's; however, the customer has not provided any follow up reports pertaining to medical intervention sought or long term injuries resulting from the incident.It was reported the patient involved did not complain of any injuries at the time of incident.There has also been no follow up reports indicating the patient claimed any injury as a result of the incident.Based on the information provided we do not believe any serious injuries were incurred.

Event Description

It was reported that while transporting a patient down the steps at the patient's home, the medic lost their grip and the patient fell into one medic's leg and the other medic's knee and arm.It was then alleged the handles on the top of the chair had broken.It was reported the patient stated she hit her head on the wall but there were no complaints of injury.Both emt's alleged pain due to the patient falling into them but it was not reported that they sought any medical intervention or that they suffered any long term effects.The chair will return to manufacturer for evaluation.

• Brand Name: MODEL 40 OS STAIR CHAIR
• Type of Device: MODEL 40 OS 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: 5270492
• MDR Text Key: 32773100
• Report Number: 1523574-2015-00088
• 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: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: 0714851
• Device Catalogue Number: PT4010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2002
• 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