MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number TRSX58FBP

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

End user is stating that the leg extenders are to short, with a broken ankle and knee she needs her leg to remain straight.End user is also stating that the leg extenders don't stay in place.Sometimes the wheels just spins and she can't get traction.The chair has been known to tip forward with her in it.

Manufacturer Narrative

The enduser gave serial number (b)(4).Based on the serial number it was concluded that this was not manufactured by invacare and an oem notification will be sent to the manufacture.

Event Description

End user is stating that the leg extenders are to short, with a broken ankle and knee she needs her leg to remain straight.End user is also stating that the leg extenders don't stay in place.Sometimes the wheels just spins and she can't get traction.The chair has been known to tip forward with her in it.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JUMAO HEALTHCARE EQUIPMENT; jiashan OH ; CH
• Manufacturer (Section G): JUMAO HEALTHCARE EQUIPMENT; jiashan OH ; CH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5250337
• MDR Text Key: 32305586
• Report Number: 1525712-2015-05513
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX58FBP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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