MAUDE Adverse Event Report: INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number TA4

Device Problems Break (1069); Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The dealer states the consumer was going down the road and the right camber tube broken and the chair flipped over.The consumer was not injured, just shaken up.

Manufacturer Narrative

Follow up to be sent if additional information is received.

Event Description

The dealer states the consumer was going down the road and the right camber tube broken and the chair flipped over.The consumer was not injured, just shaken up.

Manufacturer Narrative

Product part has been returned and evaluated, utilizing the existing complaint information and actual observation of the returned product in its received condition, the complaint was confirmed of having a camber tube break.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, MECHANICAL
• 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: 4820973
• MDR Text Key: 5902403
• Report Number: 1525712-2015-03319
• 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: 05/15/2015

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: TA4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2015
• 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
• Patient Outcome(s): Other