MAUDE Adverse Event Report: RUBBERMAID MEDICAL SOLUTIONS INC./HEALTHCARE PRODUCTS INC. 55 AMP HIGH EFFICIENCY AC COMPUTER CART; MEDICAL DEVICE DATA SYSTEM

Model Number 1781707

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 09/21/2015

Event Type  malfunction  

Event Description

There are approximately 170 rubbermaid m40 mobile carts that are used in all areas of our institution.During the last 8 days, we have experience 3 fires associated with these devices.All fires were experienced in the critical care units.Upon opening the units after the fire, it appears that some of the components on the circuit board are getting really hot and catching on fire.At this time, we are not sure if the actual fire is a result of a faulty electrical component such as a capacitor/transistor or if it is the result of heat build up due to excessive lint in the power supply area.All failed units were manufactured in 2011.

• Brand Name: 55 AMP HIGH EFFICIENCY AC COMPUTER CART
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• Manufacturer (Section D): RUBBERMAID MEDICAL SOLUTIONS INC./HEALTHCARE PRODUCTS INC.; 8935 northpoint executive drive; huntersville NC 28078
• MDR Report Key: 5112576
• MDR Text Key: 27166398
• Report Number: 5112576
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 1781707
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TRIPP LITE POWER MODULE (PART OF THE MOBILE MEDICA