MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP WET BLACK EURO NARROW BASE W/ 23-1 SSD GEAR BOX; WHEELCHAIR, POWERED

Model Number TDXSP-CG

Device Problems Leak/Splash (1354); Noise, Audible (3273)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

(b)(6) - (b)(6) 2015 - should additional information become available, a supplemental record will be filed.

Event Description

Dealer states that the motors are making noise and leaking.Caused for the customer to get stranded and received sunburn and had to get medical attention.

Manufacturer Narrative

The device was evaluated by the returns department which found that the output shaft was leaking during bench test.

Event Description

Dealer states that the motors are making noise and leaking.Caused for the customer to get stranded and received sunburn and had to get medical attention.

• Brand Name: TDXSP WET BLACK EURO NARROW 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: 4990056
• MDR Text Key: 22497009
• Report Number: 1525712-2015-04186
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TDXSP-CG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• 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): Required Intervention
• Patient Weight: 132