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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 59T EZ-GLIDE POWERTRAXX
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FERNO-WASHINGTON, INC. 59T EZ-GLIDE POWERTRAXX Back to Search Results
Model Number 0731371
Device Problem Detachment Of Device Component (1104)
Patient Problem Injury (2348)
Event Date 01/30/2018
Event Type  Injury  
Event Description
It was reported while transporting a (b)(6) patient down a flight of stairs one of the track belts on the chair allegedly snapped causing the weight of the load to shift.The transport was able to be continued by carrying the chair; however, a medic is alleging a back injury as a result.It was reported the medic sought medical intervention for the alleged injury and required therapy and time off work.
 
Event Description
It was reported while transporting a (b)(6) patient down a flight of stairs one of the track belts on the chair allegedly snapped causing the weight of the load to shift.The transport was able to be continued by carrying the chair; however, a medic is alleging a back injury as a result.It was reported the medic sought medical intervention for the alleged injury and required therapy and time off work.
 
Manufacturer Narrative
The complainant is an authorized technician for ferno products and advised that they had already installed a new track on the chair and did not require an evaluation from an outside field technician.Upon repair the chair was returned to service.The chair was over 5 years old at the time of incident and the tracks are considered a wear item on the device which require routine inspection and replacement due to the stresses placed on them during use.The complainant confirmed the medic did seek orthopedic medical intervention for the alleged back injury; however, no additional details were provided.The ifu for the product provides sufficient instructions for the inspection and/or replacement of high use components as well as guidance on maintaining control of the chair during a patient transport.
 
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Brand Name
59T EZ-GLIDE POWERTRAXX
Type of Device
59T EZ-GLIDE POWERTRAXX
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
MDR Report Key7282030
MDR Text Key100416957
Report Number1523574-2018-00013
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Emergency Medical Technician
Device Model Number0731371
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight227
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