MAUDE Adverse Event Report: LINET LINET

Model Number IMC1350-350

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

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

Event Date 04/25/2016

Event Type  malfunction  

Event Description

Pt transferred from operating room table to inpatient bed.Hob elevated to 20 degree.Pt transported out of room with anesthesia and operating room nurse.After moving about 6 feet down the hallway, the bed position changed into reverse trendelenburg.No one was touching the bed controls when the bed position began changing.Stopped in the hallway and attempting to correct the positioning.The bed was plugged in and we were unable to fix the position.We continued through the hallway to pacu and again attempted to fix the positioning.We were unsuccessful and the pt had to be transferred from that bed to another bed with a slideboard and pillows.

• Brand Name: LINET
• Type of Device: LINET
• Manufacturer (Section D): LINET; charlotte NC 28269
• MDR Report Key: 5633743
• MDR Text Key: 44572765
• Report Number: MW5062092
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 05/02/2016

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: Health Professional
• Device Model Number: IMC1350-350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 59