MAUDE Adverse Event Report: JOERNS HEALTHCARE EASYCARE 2003 ELECTRIC BED; PATIENT ELECTRIC BED

Model Number B684BED

Device Problem Sparking (2595)

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

Event Date 04/30/2017

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the end user, per the end user the bed was plugged into the wall outlet.A small flame flashed at the wall outlet and went across the wall a small distance.The side of the mattress and blankets on that side were destroyed by the fire flash.This event was witnessed by a staff member that was in the room.They called out for help, additional staff brought a fire extinguisher and the fire department was called.The resident was not in the room when the event occurred.There were no injuries sustained by staff or resident.(b)(4) were entered into our system to have the bed returned to joerns for investigation.As of this writing, the bed has not been returned.

• Brand Name: EASYCARE 2003 ELECTRIC BED
• Type of Device: PATIENT ELECTRIC BED
• Manufacturer (Section D): JOERNS HEALTHCARE; 5001 joerns drive; stevens point WI 54481
• Manufacturer (Section G): JOERNS HEALTHCARE; 5001 joerns drive; stevens point WI 54481
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6562820
• MDR Text Key: 75011344
• Report Number: 3009402404-2017-00027
• 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: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/12/2017

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: B684BED
• Device Catalogue Number: B684BED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1