Model Number WEVENT |
Device Problem
Overheating of Device (1437)
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Patient Problem
Fall (1848)
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Event Date 11/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Cardionet provided the device along with the single use disposable lithium thionyl battery involved in the event to braemar on 12/6/2016.Since the devices shows evidence of thermal heating, in which the devices plastic case shows signs of melting, braemar is treating this event as a reportable malfunction.The cause is unknown at this time.The investigation is on-going at this time.
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Event Description
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Braemar received information on 11/21/2016 from cardionet in which a patient reported an er920w device got hot while wearing it.The patient felt the device getting hot on their chest and quickly removed the device.The patient was not injured by the device heating in itself but was startled and did report tripping and falling upon standing up.We do not know if any injury occurred and are requesting more details.
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Manufacturer Narrative
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Braemar provided the incident device and lithium thionyl batteries to external failure analysis experts for investigation.The failure analysis experts determined that the batteries did not cause the incident since they were intact and did not vent and voltage measurements were normal.The failure analysis experts also determined internal damage to the device such as melted copper appeared to come from an external source.The failure analysis experts were able to reproduce very similar damage to a representative sample of a device and lithium thionyl batteries by heating the device and batteries inside of a microwave oven.Braemar does not know whether the original incident device was actually placed into a microwave oven nor are we able confirm or deny the original incident claims made by the patient.Based on the opinion of the external failure experts the device and lithium thionyl batteries were not the cause for this incident.
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Search Alerts/Recalls
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