MAUDE Adverse Event Report:; REMOTE FOR CHAIR WITH AUTO LIFT

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2014

Event Type  Other  

Event Description

Call purchased a control operated chair that stands the person sitting in it on their feet from the seated position in (b)(6) 2012.However, the remote has had to be replaced four times already and the fifth time will be (b)(6) when she receives replacement for the most recent that was overheating.She was sitting in her chair on (b)(6) 2014 when her friend walked in and said, "your remote is smoking." the caller tried to use it to move her chair up so that she could get away from it, but it would not move.She and her friend unplugged the remote and then her friend helped her get out of the chair.There were no injuries.The caller has contacted the manufacturer, but does intend to contact them when she finds who they are because she states that the retailer will not inform her of the identity of the manufacturer or their contact info.(b)(6).Explanation: retailer refused to share info for manufacturer other than "(b)(6)." (b)(4).

• Brand Name: UNK
• Type of Device: REMOTE FOR CHAIR WITH AUTO LIFT
• MDR Report Key: 4199277
• MDR Text Key: 5147911
• Report Number: MW5038791
• Device Sequence Number: 1
• Product Code: INO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1