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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED
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INVACARE TAYLOR STREET POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED Back to Search Results
Model Number TDXSP-CG
Device Problems Component Falling (1105); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The underlying cause documented on the irs or return fields in oracle is identified as: to legal dept.For further eval.No further information provided.Mdr is being submitted as a result of a retrospective complaint review.
 
Event Description
Screws came apart inside of the motor which caused the wheels to fall off.
 
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Brand Name
POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
Type of Device
WHEELCHAIR, POWERED
Manufacturer (Section D)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer (Section G)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5754922
MDR Text Key48866874
Report Number1525712-2016-02269
Device Sequence Number1
Product Code ITI
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
Report Date 12/17/2010
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTDXSP-CG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2010
Is the Reporter a Health Professional? No
Date Manufacturer Received12/17/2010
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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