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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL

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INVAMEX TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TREX2
Device Problems Bent (1059); Device Operates Differently Than Expected (2913); Positioning Problem (3009); Wheel (3130)
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

Chair having issue with the rear right wheel. The customer said the wheel appears bent and wobbles when they push the chair. The customer says, without weight in the chair the right wheel rubs in one place as it is moved. However if there is over 100lbs in the chair first one wheel will rub then the other wheel rubs. With over about 150lbs the chairs cannot be propelled easily. Initially we thought that replacing just the right wheels would solve the problem, but now we believe the frame may be compromised and we would like to replace both of the chairs.

 
Manufacturer Narrative

The device was returned and it was found that the frame was bent.

 
Event Description

Chair having issue with the rear right wheel. The customer said the wheel appears bent and wobbles when they push the chair. The customer says, without weight in the chair the right wheel rubs in one place as it is moved. However if there is over 100lbs in the chair first one wheel will rub then the other wheel rubs. With over about 150lbs the chairs cannot be propelled easily. Initially we thought that replacing just the right wheels would solve the problem, but now we believe the frame may be compromised and we would like to replace both of the chairs.

 
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Brand NameTRANSPORT 20 IN X 16 IN 9153637574
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 Key5108413
MDR Text Key27070380
Report Number9616091-2015-02371
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
Type of Report Initial,Followup
Report Date 10/05/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTREX2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/05/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2015
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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