MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; MDR107003E

Model Number MDR107003E

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the end-user purchased the bed on the internet and the same day that her son assembled the bed in the home, prior to the bed being used, the motor started sparking and smoking.The end user disassembled the bed and had it removed from her home.The motor was returned to the manufacturer for evaluation and it was noted that the power cord was charred / melted around the auxiliary battery area.The root cause of the issue is unknown.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

The motor on the bed was sparking and smoking after assembly.

• Brand Name: MEDLINE
• Type of Device: MDR107003E
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10868687
• MDR Text Key: 218230276
• Report Number: 1417592-2020-00143
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 40080196321002
• UDI-Public: 40080196321002
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDR107003E
• Device Catalogue Number: MDR107003E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1