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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 TDXSPREE-CG
Device Problems Unintended System Motion (1430); Mechanics Altered (2984)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The dealer alleges that the left side seized up and in turn locked the wheel up when they were going down a ramp.Due to the wheel locking up, the chair just did a 180 turn but the child in the chair did not fall off of the ramp or sustain any injury.He also alleges that the attendant control has been intermittent when going forward or sideways.He alleges that it slows down and he's already re-calibrated and done other troubleshooting to figure out why it slows down.
 
Manufacturer Narrative
Should additional information become available, a supplemental record will be filed.
 
Manufacturer Narrative
The device was evaluated by the returns department which found that the unit tested fully functional.Not able to duplicate issue.
 
Event Description
The dealer alleges that the left side seized up and in turn locked the wheel up when they were going down a ramp.Due to the wheel locking up, the chair just did a 180 turn but the child in the chair did not fall off of the ramp or sustain any injury.He also alleges that the attendant control has been intermittent when going forward or sideways.He alleges that it slows down and he's already re-calibrated and done other troubleshooting to figure out why it slows down.
 
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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 Key4945062
MDR Text Key20151522
Report Number1525712-2015-04051
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,distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 08/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTDXSPREE-CG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2015
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
Patient Sequence Number1
Patient Outcome(s) Other;
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