MAUDE Adverse Event Report: ENOVATE MEDICAL MOBIUS POWER MOBIUS POWER; LITHIUM BATTERY

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

Patient Problem Injury (2348)

Event Date 01/06/2017

Event Type  Injury  

Event Description

At approx 10:54 am on (b)(6) 2017, a popping sound was heard coming from a mobile workstation battery charger.The unit then started to produce a large amount of smoke and flame.Three batteries were included with one being completely destroyed.The fire was suppressed.The fire caused a great amount of smoke resulting in evacuation of the pt care unit to a different floor.Two visitors and four staff members were treated for smoke inhalation.No pts were involved or harmed.The battery was being charged at the time.The mfr is replacing all batteries and chargers with a newer model.The organization is performing a risk assessment to identify any other sources of lithium or lead acid batteries.

• Brand Name: MOBIUS POWER
• Type of Device: LITHIUM BATTERY
• Manufacturer (Section D): ENOVATE MEDICAL MOBIUS POWER; 1152 park ave; murfreesboro TN 37129
• MDR Report Key: 6249331
• MDR Text Key: 64766116
• Report Number: MW5067217
• Device Sequence Number: 0
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention