MAUDE Adverse Event Report: INVACARE TAYLOR STREET MECHANICAL CHAIR/TRANSPORT CHAIR; 890.3100

Model Number HTR5500

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

According to the customer the end cap, locknut and bearing popped off the chair.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: 890.3100
• 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: patricia medina ; one invacare way; elyria, OH 44035 ; 9999999999
• MDR Report Key: 3577370
• MDR Text Key: 4144134
• Report Number: 1525712-2014-00301
• Device Sequence Number: 1
• Product Code: INM
• 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: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HTR5500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2014
• 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 Outcome(s): Other