MAUDE Adverse Event Report: ENOVATE MEDICAL ENOVATE MEDICAL MOBIUS POWER; MOBIUS POWER IND. BATTERY 26 AH

Device Problems Fire (1245); Sparking (2595); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, at approx 1:45pm, a wow battery, in the charging bay located in an in-patient above area of our burn center failed, causing a battery de-gassing issue.This initial battery failure also produced black soot marks on two add'l batteries in the charging bay.It appears that only one of these three batteries shows signs of bulging.(b)(6) fire dept responded to site, as well as teams from engineering and is.As the batteries were being transferred to an engineering containment area, one battery sparked and flamed.The fire dept extinguished the flame and directed this battery to be placed in a men's room lavatory to contain it until it could be transferred to a hazmat container.The resulting smoke and noxious odors from this fire caused a lock down of employed personnel in this area for approx 45 minutes, until air scrubbers could be deployed to clear the smoke and odor.There are no reported staff or pt injuries reported from this incident.All offending batteries involved with this incident are now in a hazmat container awaiting further action.On (b)(6) 2015, battery failed in our nicu area, resulting in fire, which was controlled by the (b)(6) fire dept.This fire required vacating nicu pts from the area around this damage.There was no report of pt or staff injury related to this event.On (b)(6) 2016, battery failed in an in-patient area, resulting in noxious electrical overheating odor, and black soot on the battery and charging unit.Engineering team contained the damage, (b)(6) fire dept did not respond.The resulting noxious odor resulted in re-location of pts on that wing, and a staff member suffered asthma related symptoms resulting in the need to go to the ed.

• Brand Name: ENOVATE MEDICAL MOBIUS POWER
• Type of Device: MOBIUS POWER IND. BATTERY 26 AH
• Manufacturer (Section D): ENOVATE MEDICAL; murfressboro TN 37129
• MDR Report Key: 6300002
• MDR Text Key: 66476525
• Report Number: MW5067627
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention