MAUDE Adverse Event Report: UNKNOWN ELEVATING LEGREST W/ADJ CALF PAD 9153649407; FOOTREST, WHEELCHAIR

Model Number T94HE

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Dealer stated that ratchet assembly locking mechanism for the t94he front riggings on an unknown wheelchair seized up.Dealer also stated that cam was broken on one end.

• Brand Name: ELEVATING LEGREST W/ADJ CALF PAD 9153649407
• Type of Device: FOOTREST, WHEELCHAIR
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4730166
• MDR Text Key: 5735961
• Report Number: 1525712-2015-02750
• Device Sequence Number: 1
• Product Code: IMM
• 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: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T94HE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2015
• 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