JOLIFE AB - 3005445717 LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL
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Model Number LUCAS 2 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/01/2018 |
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 2 battery had burned and was emitting smoke inside a carry bag.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 2 battery had burned and was emitting smoke inside a carry bag.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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