Model Number LUCAS |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Liver Laceration(s) (1955)
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Event Date 12/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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The customer provided stryker with the available patient information.Stryker will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.The customer's device will not be returned to stryker for the evaluation.Serial number of the device is not available.Clinical review of the reported event was performed and it can not be excluded that the liver laceration was caused by lucas compressions.As described, injuries to the liver occur with both manual and mechanical cpr.
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Event Description
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A literature search identified a case of liver injury to a patient with pectus excavatum after use of the lucas device.It is unknown if the device did or did not cause or contribute to this event.
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Manufacturer Narrative
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Section d3 manufacturer entity of initial mdr indicates: physio-control, inc.- 3015876.Section d3 manufacturer entity of initial mdr should indicate: jolife ab - 3005445717.Section g1 manufacturing site for devices of initial mdr indicates: physio-control, inc.- 3015876.Section g1 manufacturing site for devices of initial mdr should indicate: jolife ab - 3005445717.A cause of the reported issue could not be determined.
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Event Description
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A literature search identified a case of liver injury to a patient with pectus excavatum after use of the lucas device.It is unknown if the device did or did not cause or contribute to this event.
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Search Alerts/Recalls
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