ENOVATE MEDICAL MOBIUS POWER 3118313

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-01 for ENOVATE MEDICAL MOBIUS POWER 3118313 manufactured by Enovate Medical.

Event Text Entries

[66476525] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067627
MDR Report Key6300002
Date Received2017-02-01
Date of Report2017-02-01
Date of Event2017-01-31
Date Added to Maude2017-02-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENOVATE MEDICAL MOBIUS POWER
Generic NameMOBIUS POWER IND. BATTERY 26 AH
Product CodeFCO
Date Received2017-02-01
Model Number3118313
Catalog Number3118313
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerENOVATE MEDICAL
Manufacturer AddressMURFRESSBORO TN 37129 US 37129


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-02-01

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