STINGER LITHIUM-ION RECHARGEABLE CELL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-03 for STINGER LITHIUM-ION RECHARGEABLE CELL manufactured by Stinger Medical Boston Power Inc..

Event Text Entries

[3698107] Around 2 pm on monday (b)(6) 2013, doctor in ed noted a burning smell. It was tracked to a storage room with blanket warmers, medication cart, and battery chargers. It was discovered that the battery in the charger overheated and was smoking. The unit was removed from the wall and taken outside extinguished. We notified the stinger company and they sent their representative to investigate and examine battery and battery pack. We had nine patients that were near the area of the event, but were evacuated to other parts of the ed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5030808
MDR Report Key3215936
Date Received2013-07-03
Date of Report2013-07-03
Date of Event2013-07-01
Date Added to Maude2013-07-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTINGER LITHIUM-ION RECHARGEABLE CELL
Generic NameSONATA 24400 AND SWING 4400
Product CodeFCO
Date Received2013-07-03
Lot Number311731311093185
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerSTINGER MEDICAL BOSTON POWER INC.
Manufacturer AddressWESTBOROUGH MA 01581396 US 01581 3961


Patients

Patient NumberTreatmentOutcomeDate
10 2013-07-03

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