MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP FOR FORMULA CG WITH MK6I; WHEELCHAIR, POWERED

Model Number NA:TDXSP-CG

Device Problem Positioning Failure (1158)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

Due to the fact that the product will not be returned, a detailed investigation of the product could not be performed.While an adverse event took place, it seems that this event happened due to the end user snagging the wiring harness to the tilt actuator on something, ripping it out, and then continuing to use the chair causing pressure sores which contributed to the leg amputation along with other pre-existing medical conditions.Should additional information become available, a supplemental record will be filed.

Event Description

The end user has a tdxsp-cg custom power wheelchair and states that about 4 months ago, he must have snagged the wiring harness to the tilt actuator on something and ripped it out, causing the lift and tilt to stop working.The end user continued to use the chair and because he could not weight shift he developed pressure sores and was hospitalized for wound care and had to have his leg amputated.

• Brand Name: TDXSP FOR FORMULA CG WITH MK6I
• 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7927204
• MDR Text Key: 122370750
• Report Number: 1525712-2018-00047
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:TDXSP-CG
• Device Catalogue Number: TDXSP-CG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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; Disability