JOLIFE AB - 3005445717 LUCAS ® CPR CHEST COMPRESSION SYSTEM; 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 Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 # 3005445717-2020-00006.Physio-control performed a clinical review of the reported event and determined that user error contributed to the serious injury of the patient.The patient had his arm strapped to the device with the patient straps during the prolonged resuscitation.This resulted in compartment syndrome to the patient's left hand.
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Event Description
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Physio-control was made aware of the article "compartment syndrome of the hand as a complication of prolonged mechanical cardiopulmonary resuscitation" published in anaesthesia reports 2020-8, that mentioned a patient event where the device use had potentially caused compartment syndrome in a 45-year-old male patient during mechanical cardiopulmonary resuscitation.Cardiopulmonary resuscitation along with aggressive rewarming achieved return of spontaneous circulation.Despite preservation of neurological function the patient died of complications from the cardiac arrest after an extended intensive care unit stay.
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Search Alerts/Recalls
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