MAUDE Adverse Event Report: ENOVATE MEDICAL/ STINGER MEDICAL MOBIUS POWER 3.5 BATTERY PACK; MOBIUS POWER 3.5 BATTERY BOCK RECHARGEABLE

Model Number MOBIUSPOWER

Device Problems Material Rupture (1546); Smoking (1585); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  Injury  

Event Description

Staff heard noises and hissing from wall mounted battery charger and visually saw smoke.Staff unplugged charger from outlet.Smoke alarm was triggered.Code red was called, security and engineering arrived, and while speaking to staff, a loud "explosion" was heard from the wall charger assembly, which contained one battery pack.Engineering grabbed the fire extinguisher and doused the charging assembly and battery.The fire department arrived and the battery and charger was removed.No injuries were reported.Per fda h0260 01: any actions taken by the manufacturer/facility: manufacturer was notified and will replace all 3.0 series battery packs immediately.Charging stations in remote, rarely occupied areas have been removed.All 3.0 series battery packs have been removed from service.All other batteries have been visually inspected by is dept.Fire extinguishers have been added beside all remaining charging stations.Event has been reported internally to (b)(6) and also fda medwatch.

• Brand Name: MOBIUS POWER 3.5 BATTERY PACK
• Type of Device: MOBIUS POWER 3.5 BATTERY BOCK RECHARGEABLE
• Manufacturer (Section D): ENOVATE MEDICAL/ STINGER MEDICAL; murfreesboro TN 37129
• MDR Report Key: 6983180
• MDR Text Key: 90768478
• Report Number: MW5072979
• Device Sequence Number: 1
• Product Code: FCO
• Combination Product (y/n): N
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MOBIUSPOWER
• Device Lot Number: 3ICP20/38/66-5
• Was Device Available for Evaluation?: Yes
• 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