A customer contacted stryker to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the thoracic ribs had multiple fractures, heart wall had hemorrhages and the bronchus had torn.The patient associated with the reported event did not survive, however the customer confirmed that the device did not contribute to the patient death.
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This mdr is being submitted to correct the incorrect fda registration number that was previously submitted under uf/importer report number # 3005445717-2021-00012.Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Stryker performed a clinical review and it was determined that it can not be excluded that some of the injuries were caused by lucas cpr.Lucas was not believed to have contributed to the patient´s death.The device passed functional and performance testing and was returned to the customer.Root cause of the reported injury remain unknown, however broken ribs and sternal fracture is a side affect of cpr and the use of the lucas device.Furthermore, the customer noted that stabilization straps were not used as instructed in the oi.The stabilization strap secures the position of the device in relation to the patient to ensure correct positioning over chest.If the pressure pad is not in the correct position in relation to the sternum, there is an increased risk of damage to the rib cage and internal organs.
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