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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403 WHEELCHAIR, MECHANICAL

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INVAMEX TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TRSX5
Device Problem Bent (1059)
Patient Problem Discomfort (2330)
Event Type  Malfunction  
Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

 
Event Description

The tbm called in stating that he visited one of his dealers that provided a trsx5 wheelchair to an end user that has a prior head injury. The tbm stated that the end user is really beating up the chair due to his prior injury. He stated that one of the back canes are bent and the frame is bent. No alleged injury. No additional information provided. Update from 1/15/16 provided by current therapy: dealer states that the unit pivot links have broken, the cross braces and the back cane have bent the clothing guards have snapped due to the bending and he has gotten pinched in the process. Dealer stated that the invacare sales rep saw the chair and states that the chair did not hold up to its weight capacity of 300lbs. Dealer provided a loaner for patient until new chair is ordered.

 
Manufacturer Narrative

Product was returned for evaluation. The return fields in oracle state: standard wheelchairs. Frame, crossbrace damage. Chair was torn down to pieces before returned. In very used condition for age. Pivot link bent on left side broken clothing guard on left side. Product received expanded evaluation. The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the tracer sx5 wheelchair of having broken pivot links or a bent cross brace. It was confirmed that the wheelchair had one back cane, a fractured right clothing guard, one bent pivot link, and wear to both anti-tippers. 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: standard wheelchairs. Frame, crossbrace damage. Chair was torn down to pieces before returned. In very used condition for age. Pivot link bent on left side broken clothing guard on left side. Product received expanded evaluation. The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the tracer sx5 wheelchair of having broken pivot links or a bent cross brace. It was confirmed that the wheelchair had one back cane, a fractured right clothing guard, one bent pivot link, and wear to both anti-tippers. The tbm called in stating that he visited one of his dealers that provided a trsx5 wheelchair to an end user that has a prior head injury. The tbm stated that the end user is really beating up the chair due to his prior injury. He stated that one of the back canes are bent and the frame is bent. No alleged injury. No additional information provided. Update from (b)(4) 2016 provided by current therapy: dealer states that the unit pivot links have broken, the cross braces and the back cane have bent the clothing guards have snapped due to the bending and he has gotten pinched in the process. Dealer stated that the invacare sales rep saw the chair and states that the chair did not hold up to its weight capacity of 300lbs. Dealer provided a loaner for patient until new chair is ordered.

 
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Brand NameTRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
Type of DeviceWHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5387902
MDR Text Key36773813
Report Number9616091-2016-00106
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 COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 02/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTRSX5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2016
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

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