MAUDE Adverse Event Report: ENOVATE MEDICAL MOBIUS POWER MEDICAL CART BATTERY; LITHIUM-ION BATTERY FOR CART

Device Problems Fire (1245); Smoking (1585); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 06/04/2015

Event Type  Injury  

Event Description

At 0144 in the morning, a lithium-ion battery used to power a hospital workstation on wheels caught fire while in its wall mounted charging station.A hospital staff member heard hissing and popping, followed by smoke then fire; 911 was called and the hospital's intensive care pts had to be evacuated.Five hospital staff members reported inhaling smoke, but no injuries otherwise resulted.Clean-up on the unit took a week to complete.This is the second time this year a battery from the same company has resulted in a fire within our hospital system.While the battery is not a medical device per se, the malfunction affected pt care.An ecri alert was released related to the matter.

• Brand Name: MOBIUS POWER MEDICAL CART BATTERY
• Type of Device: LITHIUM-ION BATTERY FOR CART
• Manufacturer (Section D): ENOVATE MEDICAL; murfreesboro TN
• MDR Report Key: 4945812
• MDR Text Key: 6256282
• Report Number: MW5044781
• Device Sequence Number: 1
• Product Code: FCO
• 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: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention