MAUDE Adverse Event Report: LINET MULTICARE LE

Model Number 1MC5A650-23

Device Problems Detachment Of Device Component (1104); Device Tipped Over (2589)

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

Event Date 05/08/2015

Event Type  malfunction  

Event Description

When turning a pt in a linet bed, which includes a tilt function, on his side the bed began to tip over and the rear wheel on the left side came off of the ground.The side rail was up so the pt's weight shifted toward the rail.The nurses called for help and other staff arrived to hold the bed down.The tilt function then became inactivated due to the staff on the "down side" of the bed having some portion of their weight on the side rail as well.This extra weight on the bed caused the torque necessary to lift the opposite wheel off of the ground.Staff then had to unplug the bed to reinitialize before they could get the pt back flat on the bed.Fortunately the pt was hemodynamically stable or the outcome would have been egregious.Linet sent in the (b)(4) for quality and service operations on (b)(6) 2014.

• Brand Name: MULTICARE LE
• Type of Device: MULTICARE LE
• Manufacturer (Section D): LINET; charlotte NC 28269
• MDR Report Key: 4917675
• MDR Text Key: 6014104
• Report Number: MW5044184
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MC5A650-23
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 178