MAUDE Adverse Event Report: KNU, LLC LAZY BOY RECLINER - MEDICAL GRAD; CHAIR AND TABLE, MEDICAL

Model Number DD1307U

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2018

Event Type  malfunction  

Event Description

A (b)(6) male admitted with diverticulitis was sleeping in a recliner chair in his room.He was fully reclined with leg rest extended.He woke up to the back rest collapsing in stages.He heard 3 pops, the back rest fell in stages with each pop.He partially slid out of the chair reporting that he slightly hit his head on the floor or the linen container.He reports no injury.It was determined that the interior 2 brackets on the backs of recliners that hold the back to the seat were loosening via loose screws.

• Brand Name: LAZY BOY RECLINER - MEDICAL GRAD
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): KNU, LLC; ferdinand IN 47532
• MDR Report Key: 8078548
• MDR Text Key: 127855408
• Report Number: MW5081376
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2018

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: DD1307U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 96