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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 Problems Frame (820); Bent (1059); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The dealer states that out of the box the front seat frames are lightly bent inward and the seat upholstery is sagging.

 
Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation, and subsequent testing verified the complaint. The underlying cause could not be determined after reviewing the documentation in this investigation. Per the initial evaluation, both seat rails were bent and would not fit into the h-blocks. An expanded evaluation was performed. The expanded evaluation report confirmed that both seat rails were bent inward, did not settle properly into the h-blocks, and caused the upholstery to sag in the middle.

 
Event Description

The dealer states that out of the box the front seat frames are lightly bent inward and the seat upholstery is sagging.

 
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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 Key5354131
MDR Text Key35733798
Report Number9616091-2016-00026
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
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2016
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 Manufacturer01/14/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2016
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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