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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL

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INVAMEX TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number 9SL_PTO_34745
Device Problem Bent (1059)
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

Dealer states that the left crossbrace is bent.

 
Manufacturer Narrative

Product was returned for evaluation. The return fields in oracle state: standard wheelchairs. Frame, crossbrace damage. 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 confirmed for the bend in the seat rail, but the reason for the bend in the seat rail could not be determined. It could possibly been for some type of damage to the seat rail. 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. 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 confirmed for the bend in the seat rail, but the reason for the bend in the seat rail could not be determined. It could possibly been for some type of damage to the seat rail. Dealer states that the left crossbrace is bent.

 
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Brand NameTRANSPORT 20 IN X 16 IN 9153637574
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 Key5386011
MDR Text Key36660461
Report Number9616091-2016-00101
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
Type of Report Initial,Followup
Report Date 02/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number9SL_PTO_34745
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2016
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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