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

Model Number 0714851

Device Problems Mechanical Problem (1384); Device Slipped (1584); Device Tipped Over (2589); Unintended Movement (3026)

Patient Problems Fall (1848); Injury (2348)

Event Date 04/12/2016

Event Type  No Answer Provided  

Event Description

It was reported that while removing a patient from her residence to the ambulance via the stair chair, the emt was rolling the patient down a ramp when the back wheels allegedly slid out and the patient went over backwards in the chair.The emt was allegedly injured by taking the brunt of the impact to the ground as he was trying to hold the chair and control the fall so as not to injure the patient.The complainant has not reported any injury to the patient and they have also not provided any further specific details regarding the incident or the alleged injury.An investigation has been initiated and the stair chair will be returned to ferno for evaluation.

Manufacturer Narrative

The product was returned to manufacturer on 5/2/2016.A visual and functional evaluation was conducted on the product and there were no malfunctions found that would have contributed to the alleged incident.There was an observation of two bent components on the chair; however, neither component would have contributed to the alleged incident.It could not be determined when these components were damaged but it was recommended to the customer to repair these components before returning the product to service.The complainant was contacted to follow up on the details of the reported incident and the alleged injury.The customer was unable to provide any additional details and stated all of the information they had was recorded in the initial complaint.A follow up letter was sent to the customer to advise the manufacturer if they become aware of any reports of further alleged injury from the patient or the medic.To date, there have been no further reports of alleged injury from the patient nor any details on the alleged medic injury or if medical intervention was required.A review of the user manual reveals clear instruction on how to roll and carry the chair over flat surfaces, rough surfaces and uneven surfaces.These instructions contain a requirement the chair be operated with two trained operators and a weight limit.The complainant could not provide information about the operators or the patient weight.Based on the information provided, we do not believe the chair malfunctioned in a way to cause the incident.We believe the direct cause of the incident was loss of control of the chair by the operator.

Event Description

It was reported that while removing a patient from her residence to the ambulance via the stair chair, the emt was rolling the patient down a ramp when the back wheels allegedly slid out and the patient went over backwards in the chair.The emt was allegedly injured by taking the brunt of the impact to the ground as he was trying to hold the chair and control the fall so as not to injure the patient.The complainant has not reported any injury to the patient and they have also not provided any further specific details regarding the incident or the alleged injury.An investigation has been initiated and the stair chair will be returned to ferno for evaluation.

• Brand Name: MODEL 40 OS CHAIR
• Type of Device: MODEL 40 OS 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: 5605929
• MDR Text Key: 43566768
• Report Number: 1523574-2016-00013
• 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,Followup
• Report Date: 05/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• 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: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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