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Model Number LUCAS 3 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Physio-control evaluated the customer¿s battery and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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The customer contacted physio-control to report that their lucas 3 battery emitting an electrical smell and then the battery vented through the plastic shell.The device was in a paused and alarmed state.It was also reported that the device was warm to the touch with a new battery installed.There was no patient use associated with the reported event.Upon evaluation of the customer¿s battery, physio-control observed evidence of material leakage from the cells of the battery.Per the cell material safety data sheet, these materials include flammable organic solvents and corrosive irritants.Thus potential hazards include chemical burns from cell material exposure to sensitive tissues (eyes, skin, respiratory, gastro/respiratory) and for thermal burns resulting from ignition of vented battery cell flammable solvents.
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Manufacturer Narrative
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(b)(4).Physio-control further evaluated the battery and observed electrolyte residue, indicating electrolyte leakage from the cells.
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Event Description
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The customer contacted physio-control to report that their lucas 3 battery emitting an electrical smell and then the battery vented through the plastic shell.The device was in a paused and alarmed state.It was also reported that the device was warm to the touch with a new battery installed.There was no patient use associated with the reported event.Upon evaluation of the customer¿s battery, physio-control observed evidence of material leakage from the cells of the battery.Per the cell material safety data sheet these materials include flammable organic solvents and corrosive irritants.Thus potential hazards include chemical burns from cell material exposure to sensitive tissues (eyes, skin, respiratory, gastro/respiratory) and for thermal burns resulting from ignition of vented battery cell flammable solvents.
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Search Alerts/Recalls
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