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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL
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INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TA4
Device Problems Corroded (1131); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Dealer advised lots of bolts on chair are rusted.Dealer advised went out and cleaned chair up for enduser.Dealer advised sat in chair and noticed it was uneven.Dealer advised front right caster was off the ground about quarter to half an inch when looked at chair.Dealer advised did some adjustments to chair and still off the ground.
 
Manufacturer Narrative
Follow up to be sent if additional information is received.
 
Manufacturer Narrative
Product was returned for evaluation.The return fields in (b)(4) state: frame unable to test.Complaint of front right caster was off the ground was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.Device manufacturer updated from invacare taylor street to invacare top end to reflect the correct manufacturer.
 
Event Description
Product was returned for evaluation.The return fields in (b)(4) state: frame unable to test.Dealer advised lots of bolts on chair are rusted.Dealer advised went out and cleaned chair up for enduser.Dealer advised sat in chair and noticed it was uneven.Dealer advised front right caster was off the ground about quarter to half an inch when looked at chair.Dealer advised did some adjustments to chair and still off the ground.
 
Manufacturer Narrative
Product was returned for evaluation.Product received expanded evaluation.The expanded evaluation report states: functional observation- the wheels rolled and the casters swivel, but the left caster intermittently causes the wheelchair to three wheel.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 wheelchair three wheeling.The left caster is 1/16th of an inch higher than the right caster.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
 
Event Description
Product was returned for evaluation.Product received expanded evaluation.The expanded evaluation report states: functional observation- the wheels rolled and the casters swivel, but the left caster intermittently causes the wheelchair to three wheel.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 wheelchair three wheeling.The left caster is 1/16th of an inch higher than the right caster.Product was returned for evaluation.The return fields in oracle state: frame unable to test.Dealer advised lots of bolts on chair are rusted.Dealer advised went out and cleaned chair up for enduser.Dealer advised sat in chair and noticed it was uneven.Dealer advised front right caster was off the ground about quarter to half an inch when looked at chair.Dealer advised did some adjustments to chair and still off the ground.
 
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Brand Name
TRANSPORT 20 IN X 16 IN 9153637574
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer (Section G)
INVACARE TOP END
1200 taylor street
pinellas park FL 44036
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4873856
MDR Text Key6059114
Report Number1525712-2015-03575
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,distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTA4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/01/2015
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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