MAUDE Adverse Event Report: UNKNOWN POWERED WHEELCHAIR; 890.3860

Model Number M51

Device Problem Smoking (1585)

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

Event Date 10/12/2014

Event Type  malfunction  

Event Description

Enduser alleges had wheelchair pugged up to charge and the battery charger began to smoke.Enduser is not aware of model or serial number, but enduser states has had the chair since (b)(6), 2003 and the chair has never been serviced.Enduser has unplugged the chair and is not in use.

• Brand Name: POWERED WHEELCHAIR
• Type of Device: 890.3860
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4219323
• MDR Text Key: 5070094
• Report Number: 1525712-2014-07508
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2014
• 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