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

Model Number 0714851

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 10/28/2016

Event Type  No Answer Provided  

Event Description

During a patient transport, it was alleged the patient pinched her finger on the chair when sitting down and hit her left leg on the handle of the chair when standing up allegedly causing a one inch skin avulsion on her leg.There was no report of a malfunction of the device.It is unknown if medical intervention was required for the alleged injuries.This incident will be investigated and the product evaluated.

Manufacturer Narrative

The device was returned to manufacturer for evaluation.A visual and functional evaluation was conducted and it was observed the overall condition of the chair showed signs of wear indicative of a 6 year old product.The pivot points on the seat frame were elongated from wear which allowed the chair to rock back and forth creating a potential pinch point at the knee hinge.The complainant was contacted to inquire about the specifics of where the alleged pinch point was; however, they were unable to provide any more specifics.The device was also evaluated for any sharp edges on the lower handle; however, no sharp edges were observed.It was recommended the chair remain out of service for repair or replacement due to the age and wear of the device.No further information was provided regarding the patient's alleged injuries.A follow up letter was sent to the complainant with contact information should they become aware of additional information regarding the alleged injury.Upon review of the investigation, it appears the potential pinch point was a result of wear due to the age of the device.The user manual provides sufficient instruction on inspection and maintenance/repair of the product by the end user.

Event Description

During a patient transport, it was alleged the patient pinched her finger on the chair when sitting down and hit her left leg on the handle of the chair when standing up allegedly causing a one inch skin avulsion on her leg.There was no report of a malfunction of the device.It is unknown if medical intervention was required for the alleged injuries.This incident will be investigated and the product evaluated.

• Brand Name: 40-OS CHAIR
• Type of Device: 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: 6099701
• MDR Text Key: 59776689
• Report Number: 1523574-2016-00030
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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 Age: 83 YR