MAUDE Adverse Event Report: INVACARE TAYLOR STREET DEMO 1 PROSPIN 16X17 SHOW; WHEELCHAIR, MECHANICAL

Model Number PROX4S

Device Problems Bent (1059); Component Falling (1105); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.The product was returned for evaluation, and subsequent testing verified the complaint.The frame was bent and would not fit into the h-blocks, and the chair was three-wheeling.The underlying cause was identified as freight damage.

Event Description

Per email from customer, the screw on the test hits the tires every time you go up or down, trying to reach the insertion and lock hole for the arm.Also the arm hits/pinches the seat cushion.Also the brakes were bending and they would bend back, the brakes eventually fell off.

• Brand Name: DEMO 1 PROSPIN 16X17 SHOW
• 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: 5678212
• MDR Text Key: 45873265
• Report Number: 1525712-2016-01491
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/09/2012

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: PROX4S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2012
• Initial Date FDA Received: 05/25/2016
• 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