Catalog Number 0408660000 |
Device Problems
Fire (1245); Overheating of Device (1437); Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/06/2018 |
Event Type
malfunction
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Event Description
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The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame.The battery was removed from the flyte helmet and put into water in a sink.The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet.No patient involvement with this event.
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Manufacturer Narrative
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Device not available for evaluation; however, images were provided for examination.Lot number and manufacture date updated.Correction: device code changed to reflect updated information provided.Device not returned; however, images were provided for examination.
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Event Description
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The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame.The battery was removed from the flyte helmet and put into water in a sink.The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet.No patient involvement with this event.
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Search Alerts/Recalls
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