MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 59T EZ GLIDE POWERTRAXX STAIR CHAIR

Model Number 0731374

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

Event Type  malfunction  

Event Description

It was reported while attempting to transport a (b)(6) lb patient back into their residence, the medics leaned the chair back and heard and felt the seat hinges allegedly snap and break.The crew waited for a new chair to be delivered to the residence so they could complete the transfer.There were no reports of injury to the patient or medic crew.Initial information indicates the patient's weight was in excess of the labeled weight limit for the stair chair.

Manufacturer Narrative

The stair chair was evaluated at the complainant's site by an authorized field technician.A visual evaluation was conducted and the alleged break of the seat hinge was confirmed.The evaluation revealed abrasions on the broken areas indicating potential prior damage in the area.The cross member on the main vertical frame was bent and there was excessive play in most of the joints.Based on the evaluation observations and the information indicating use of the chair in excess of the published weight limit, it was recommended that the chair be removed from service and replaced.There was no further information provided indicating the patient was adversely affected by the delay in transport.

Event Description

It was reported while attempting to transport a (b)(6) patient back into their residence, the medics leaned the chair back and heard and felt the seat hinges allegedly snap and break.The crew waited for a new chair to be delivered to the residence so they could complete the transfer.There were no reports of injury to the patient or medic crew.Initial information indicates the patient's weight was in excess of the labeled weight limit for the stair chair.

• Brand Name: 59T EZ GLIDE POWERTRAXX STAIR CHAIR
• Type of Device: 59T EZ GLIDE POWERTRAXX 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: 6254492
• MDR Text Key: 64889453
• Report Number: 1523574-2017-00003
• 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: 03/28/2017

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: Emergency Medical Technician
• Device Model Number: 0731374
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2013
• 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
• Patient Weight: 245