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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TOP END TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL
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INVACARE TOP END TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number CT7A
Device Problems Break (1069); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available a supplemental record will be filed.
 
Event Description
The dealer stated that the frame is defective.She stated she was using it and the front caster on the right came out and the other side worked itself half way out.The dealer put the thread locks on the front casters to keep the bolt in place.The customer is still not happy because she said the threads are broken because there were shavings.The customer believes that it is a safety risk and wants the chair replaced.
 
Manufacturer Narrative
Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Frame, other/defective.After removing 1166172 stud from right side there did appear to be significant thread damage to headtube threads/the stud threads appeared to be okay.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
 
Event Description
Product was returned for evaluation.The return fields in oracle state: custom manual wheelchairs.Frame, other/defective.After removing 1166172 stud from right side there did appear to be significant thread damage to headtube threads/the stud threads appeared to be okay.The dealer stated that the frame is defective.She stated she was using it and the front caster on the right came out and the other side worked itself half way out.The dealer put the thread locks on the front casters to keep the bolt in place.The customer is still not happy because she said the threads are broken because there were shavings.The customer believes that it is a safety risk and wants the chair replaced.
 
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Brand Name
TRANSPORT 20 IN X 16 IN 9153637574
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVACARE TOP END
pinellas park FL
Manufacturer (Section G)
INVACARE TOP END
pinellas park FL
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5366298
MDR Text Key36341047
Report Number1056571-2016-00004
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 01/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCT7A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received01/27/2016
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
Patient Sequence Number1
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