Corrected information, as follows: there was/were 1 case(s) with no sample received for evaluation, a result code of operational problem and a conclusion code of failure to follow instructions.There was/were 1 case(s) with no sample received for evaluation, a result code of operational problem and a conclusion code of device not returned.There was/were 21 case(s) with no sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of device not returned.There was/were 12 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of operational context caused or contributed to event.There was/were 2 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of failure to follow instructions.There was/were 3 case(s) with a sample received for evaluation, a result code of no failure detected and a conclusion code of no failure detected, device operated within specification.The manufacturer internal reference number is: (b)(4).
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This report summarizes e2000003 37 reported events for q3 2017.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device damaged prior to use.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 unknown gender, (b)(6), unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to fold.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material discolored.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code torn material.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code device or device component damaged by another device.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code use of device issue.There was/were 10 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 7 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.
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