A device history record review is performed on each device reported in a mdr reportable event, along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii), the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
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It was reported, that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event.[repair multi-device];[mms-20-3818 syringe barrel clamp replacement, p2 mms-20-1953 software recall v12.1.1].There was no reported patient involvement.
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