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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX TREX2/WD66/ADULT/28/U67 9153653554 WHEELCHAIR, MECHANICAL

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INVAMEX TREX2/WD66/ADULT/28/U67 9153653554 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TREX26RP
Device Problems Bent (1059); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Should additional information become available for the patient a supplemental record will be filed.

 
Event Description

Dealer states the tire is bent making the chair unstable. Per the technician's evaluation, the right wheel rubs the right arm and the wheel is slightly bent.

 
Manufacturer Narrative

Per the technician's evaluation, the right wheel rubs the right arm with weight in the chair, and the arms have too much play in them. An expanded evaluation was performed. Per the expanded evaluation report, the right rear wheel did not rotate straight on the axle bolt. As it rotated, it moved between 3/8 and 1/2 of an inch away from the arm rest. The tire/wheel was not identified as being bent. The arm rests were able to detach and lock into place with the snap buttons. Therefore, the complaint of the tire/wheel being bent was not verified; however, the complaint of the chair being unstable was confirmed, as the right rear wheel would change distance between the arm rest during rotation.

 
Event Description

Dealer states the tire is bent making the chair unstable. Per the technician's evaluation, the right wheel rubs the right arm with weight in the chair, and the arms have too much play in them. An expanded evaluation was performed. Per the expanded evaluation report, the right rear wheel did not rotate straight on the axle bolt. As it rotated, it moved between 3/8 and 1/2 of an inch away from the arm rest. The tire/wheel was not identified as being bent. The arm rests were able to detach and lock into place with the snap buttons.

 
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Brand NameTREX2/WD66/ADULT/28/U67 9153653554
Type of DeviceWHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5288875
MDR Text Key33858228
Report Number9616091-2015-02873
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Replace
Type of Report Initial,Followup
Report Date 11/24/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTREX26RP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/12/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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