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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX; WHEELCHAIR, POWERED
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INVACARE TAYLOR STREET TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX; WHEELCHAIR, POWERED Back to Search Results
Model Number TDXSI-HD-S
Device Problems Leak/Splash (1354); Failure to Align (2522)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
(b)(6) states that the right motor is leaking.It has leaked on the carpet.Update info: provider advised that the new motor installed is now causing the chair to pull to the right.
 
Manufacturer Narrative
Should additional information become available a supplemental record will be filed.
 
Manufacturer Narrative
Device was returned for evaluation.The return fields in oracle state: gearbox cover gasket leaks.Tested on cmt.Amps and rpm's in range.Motor operated properly during bench test.Wiggled wires and brake handle with no failure.Unable to test under load.Complaint of right motor is leaking was confirmed.Complaint of chair to pulls to the right was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
 
Event Description
Device was returned for evaluation.The return fields in oracle state: gearbox cover gasket leaks.Tested on cmt.Amps and rpm's in range.Motor operated properly during bench test.Wiggled wires and brake handle with no failure.Unable to test under load.Edward states that the right motor is leaking.It has leaked on the carpet.Update info: provider advised that the new motor installed is now causing the chair to pull to the right.
 
Manufacturer Narrative
Product received expanded evaluation.The expanded evaluation report states: visual inspection- the motor and gearbox housing were in good condition, but there was grease leaking from the top portion of the gearbox.There was grease present on the six attachment bolts.The output shaft was in good condition, and there was grease present near the base of the shaft.Functional observation- the motor and gearbox assembly was connected to a test controller and joystick.The joystick was powered "on" and the motor and gearbox were able to drive in forward, reverse, right , and left.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the 4- pole motor and gearbox assembly of having a grease leak at the top portion of the gearbox.
 
Event Description
Product received expanded evaluation.The expanded evaluation report states: visual inspection- the motor and gearbox housing were in good condition, but there was grease leaking from the top portion of the gearbox.There was grease present on the six attachment bolts.The output shaft was in good condition, and there was grease present near the base of the shaft.Functional observation- the motor and gearbox assembly was connected to a test controller and joystick.The joystick was powered "on" and the motor and gearbox were able to drive in forward, reverse, right , and left.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the 4- pole motor and gearbox assembly of having a grease leak at the top portion of the gearbox.Device was returned for evaluation.The return fields in oracle state: gearbox cover gasket leaks.Tested on cmt.Amps and rpm's in range.Motor operated properly during bench test.Wiggled wires and brake handle with no failure.Unable to test under load.(b)(6) states that the right motor is leaking.It has leaked on the carpet.Update info: provider advised that the new motor installed is now causing the chair to pull to the right.
 
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Brand Name
TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
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 Key4909777
MDR Text Key6068277
Report Number1525712-2015-03828
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 Consumer,consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 10/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTDXSI-HD-S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2015
Is the Reporter a Health Professional? No
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
Patient Sequence Number1
Patient Outcome(s) Other;
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