This mdr is being submitted to correct the incorrect fda registration number that was previously submitted under uf/importer report number # 3005445717-2021-00008.The initial reporter¿s phone number is (b)(6).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. though stryker requested some 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.A stryker service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.After completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Clinical review of the reported event was performed.It can not be excluded that the failing of the device contributed to the patient death even if the survival rate in this transported patient population is low.
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