MAUDE Adverse Event Report: UNKNOWN 3 POSITION RECLINER DLX-X WIDE BLUE RIDGE 9153641314; CHAIR AND TABLE, MEDICAL

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It has been reported by an end user that the hand pendant on the liftout chair she has does not work, and that there could be a possible short in the hand pendant.The chair sometimes gets stuck in the up position.

• Brand Name: 3 POSITION RECLINER DLX-X WIDE BLUE RIDGE 9153641314
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4371259
• MDR Text Key: 5236857
• Report Number: 1531186-2014-07011
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2014,10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2014
• Distributor Facility Aware Date: 10/30/2014
• Date Report to Manufacturer: 12/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other