MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX; WHEELCHAIR, POWERED

Model Number 3GTQ3

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.User¿s manual review- 1143151 rev.I (page 26) warning - always wear your seat positioning strap.The seat positioning strap is a positioning strap only.It is not designed for use as a safety device withstanding high stress loads such as auto or aircraft safety straps.If signs of wear appear, strap must be replaced immediately.(page 77) every six months, and as necessary, take your wheelchair to a qualified technician for a thorough inspection and servicing.Weekly, monthly and periodic inspections should be performed by user/attendant between the six month service inspections.Regular cleaning will reveal loose or worn parts and enhance the smooth operation of your wheelchair.To operate properly and safely, your wheelchair must be cared for just like any other vehicle.Routine maintenance will extend the life and efficiency of your wheelchair.

Event Description

The reporter states the inductive is "sticking".It will not work properly.The reporter states the joystick was not working properly and when the end user went to stop, she came out of the chair and bumped her head.The end user stated she went to the doctor to get checked out and the doctor said she is fine.The reporter stated that the end user said she was in the house when she bumped her head.End user stated the chair kept moving after she let go of the joystick.The joystick would not return to neutral once released.Inductive also required more force than normal to move it according to reporter.It is unknown if end user was wearing seat strap.No further information provided.

• Brand Name: TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX
• 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: 5430051
• MDR Text Key: 38544163
• Report Number: 1525712-2016-00477
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/03/2016

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: 3GTQ3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/11/2016
• 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 Age: 20