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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 59-T EZGLIDE POWERTRAXX CHAIR
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FERNO-WASHINGTON, INC. 59-T EZGLIDE POWERTRAXX CHAIR Back to Search Results
Model Number 0731371
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2017
Event Type  malfunction  
Event Description
It was reported that while transporting a patient, the frame casting and the plastic seat on the chair cracked.The medics were able to complete the transfer down the stairs by carrying the patient on a tarp.No injuries were reported in regards to the patient or medics.
 
Manufacturer Narrative
The chair was evaluated by an authorized field technician.The complainant had already repaired the chair prior to evaluation by the technician.The technician was able to confirm the chair was repaired properly and was operating according to specification, post repair.The cause of the incident was attributed to the age of the chair and repeated use in bariatric transfer causing potential weakening of the castings over time.Sufficient instructions are provided in the ifu for regular inspection of the device for signs of excessive wear.There were no later reports of any injuries being sustained as a result of this incident.
 
Event Description
It was reported that while transporting a patient, the frame casting and the plastic seat on the chair cracked.The medics were able to complete the transfer down the stairs by carrying the patient on a tarp.No injuries were reported in regards to the patient or medics.
 
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Brand Name
59-T EZGLIDE POWERTRAXX CHAIR
Type of Device
59-T EZGLIDE POWERTRAXX 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 Key6688014
MDR Text Key79274772
Report Number1523574-2017-00026
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Paramedic
Type of Report Initial,Followup
Report Date 08/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2017
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Weight218
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