MAUDE Adverse Event Report: INVACARE TAYLOR STREET POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number 3GTQ-TS

Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

End user advised dealer replaced right wheel and as he was driving in a parking lot at school, he heard a popping noise and then a screw came out, went another ten feet heard another popping noise and another screw came out and someone in the parking lot helped him and while tightening another screw popped out from wheel and or gb motor.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5273028
• MDR Text Key: 33352506
• Report Number: 1525712-2015-05613
• Device Sequence Number: 1
• Product Code: ITI
• 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: Patient
• Type of Report: Initial
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3GTQ-TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• 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