MAUDE Adverse Event Report: LINET AMERICAS LINET; LINET MULTICARE BED

Model Number MULTICARE

Device Problems Crack (1135); Malposition of Device (2616)

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

Event Type  malfunction  

Event Description

Weld is cracking in the same place on 17 out of 20 icu beds at the medical center.The weld location is at a point that attaches the knee-lift actuator motor bracket to the frame.This causes the motor to drop lower.Some are cracking worse than others.

• Brand Name: LINET
• Type of Device: LINET MULTICARE BED
• Manufacturer (Section D): LINET AMERICAS; charlotte NC 28269
• MDR Report Key: 7078643
• MDR Text Key: 93762063
• Report Number: MW5073683
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MULTICARE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1