This mdr is being submitted to correct the incorrect fda registration number that was previously submitted under uf/importer report number # 3005445717-2021-00006.A stryker clinical specialist performed a clinical review and it was determined that due to lack of information it can not be excluded or confirmed that the reported injuries could have been caused by cpr, manual or mechanical.The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device has not been returned to stryker for evaluation for this reported issue.The reported issue could not be verified and the cause of the reported issue could not be determined.The device was evaluated in august 2021 and the device passed all functional and performance testing.
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