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

Model Number TA4

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Loss of consciousness (2418)

Event Type  Injury  

Event Description

End user reported that he has fallen out of his ta4 wheelchair chair a couple of times.End user stated that he started having issues due to a relapse from a previous stoke (lost functions on the left side), had become more dependent on the wheelchair.End user reported that he was trying to transfer from the wheelchair to go to the restroom, the chair got away from him due to the brakes (wheel locks) not working properly.He fell, hit is head, became unconscious and woke up several hours later.End user advised this has happened a couple of times.End user advised his apartment building personnel said he was confused and they called 911 to take him to the hospital.End user advised he had a mri and other tests.End user advised hospital stated he could not leave without a wheelchair.End user advised he does not remember everything that happened.End user advised that the right brake (wheel lock) fell off and the left brake (wheel lock) does not hold.End user advised to many screws on the chair and it is wobbly and the frame is lopsided.End user could not provide any further information.

• 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 44036 ; 8003336900
• MDR Report Key: 4505751
• MDR Text Key: 5487337
• Report Number: 3008262382-2015-00511
• Device Sequence Number: 1
• Product Code: CAW
• 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
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TA4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2015
• 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
• Patient Outcome(s): Hospitalization; Other