JOLIFE AB - 3005445717 LUCAS 2, 2.2, IN SHIPPING BOX,EN,DA,SV,FI,NO; COMPRESSOR, CARDIAC, EXTERNAL
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Model Number LUCAS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Liver Laceration(s) (1955)
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Event Date 03/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr 3005445717-2020-00004.Physio-control performed an clinical review and determined that based on the available information, the device use may have contributed to the patient outcome.It can not be excluded that the liver lacerations occur when providing chest compressions during both manual and mechanical cpr.Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.Not returned to manufacturer.
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Event Description
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The customer contacted physio-control to report that their device had potentially caused liver laceration, a broken rib, and refractory bleeding, during patient use.
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