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

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.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, 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 Key: 5386011
• MDR Text Key: 36660461
• Report Number: 9616091-2016-00101
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9SL_PTO_34745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• 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
• Patient Sequence Number: 1