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

Model Number HTR5500_PTO_35378

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Right front wheel broken.

Manufacturer Narrative

Follow up to be sent if additional information is received.

• 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: 4913113
• MDR Text Key: 6054964
• Report Number: 1525712-2015-03851
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/18/2015

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: HTR5500_PTO_35378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 07/14/2015
• 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