MAUDE Adverse Event Report: INVACARE TAYLOR STREET TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403; WHEELCHAIR, MECHANICAL

Model Number TA4

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

No regular maintenance records can be provided.No return anticipated, as end user was referred to a service provider.The underlying cause of the alleged break of the frame is unknown; however, it was reported that the end user was pulling the ta4 up the stairs with a belt around their neck and there was multiple alleged malfunctions.The underlying cause is most likely physical damage.Should additional information become available a supplemental record will be filed.

Event Description

The end user stated the chair is broken at the back, where the back cane meets the frame.End user stated the push handles have been broken.End user stated the arm rests are broken and the seat belt is broken.End user went on to state he needs casters and wheels.Update from customer service on 7/28/16: end user stated he uses a belt around his neck and pulls the chair up the stairs causing back pain.Update from consumer affairs 8/1/16: no alleged malfunction to cause alleged injury.End user is transporting chair up stairs with a belt around his neck which is not advised, the chair is not causing the alleged soreness but the way he is attempting to transport the chair is the cause.End user is not aware of what caused the frame or back canes to break.No further information was available.

• Brand Name: TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403
• 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: 5842706
• MDR Text Key: 51063329
• Report Number: 1525712-2016-02536
• 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
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• 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