Model Number 0.850.0021 |
Device Problems
Overheating of Device (1437); Battery Problem (2885)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation has not been conducted as all affected components have not yet been received.It is anticipated that aribex will receive the affected components and an evaluation will be conducted.A follow-up report will be submitted upon evaluation completion.
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Event Description
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It was reported that the charging cradle has melted and is no longer working.The battery was not on the cradle at the time.There was no report of injury, user or patient involvement, or impact to patient care.
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Manufacturer Narrative
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The unit was returned and an evaluation was completed.Upon visual inspection it appears that a thermal event occurred.It is not possible to determine the exact sequence of events that led to the thermal event.However, there is evidence that a short occured in the lower battery pack between the cells and printed circuit board.There was a blackening on the top of the lower battery pack and its printed circuit board.Cells 2 and 3 appear to have been involved in the thermal event, likely by supplying energy into a fault in the board.Additionally there was a slight melting of the handset plastic enclosure.This concludes the investigation.A recall was conducted and termination of the recall has been requested.Reference (b)(4).
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Search Alerts/Recalls
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