MAUDE Adverse Event Report: INVACARE TAYLOR STREET HTR5500 HTR-DELUXE MODEL 5500 9153635378; CHAIR AND TABLE, MEDICAL

Model Number HTR5500

Device Problems Bent (1059); Component Missing (2306)

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

Event Type  malfunction  

Event Description

The dealer alleges the right arm support is wobbly.Additional non-reportable complaint for this device; the dealer states the tray support/slider bars have become slightly bent.The knobs on the tray are missing.They come unscrewed and the staff fails to tighten them.The legrest calf support is missing a knob.She also states the chair needs a general tune up/check up.

• Brand Name: HTR5500 HTR-DELUXE MODEL 5500 9153635378
• Type of Device: CHAIR AND TABLE, MEDICAL
• 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: 4655563
• MDR Text Key: 5607144
• Report Number: 1525712-2015-02206
• Device Sequence Number: 1
• Product Code: FRK
• 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: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• 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: 03/25/2015
• 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