Device review: the pt did not request service from the mfr's regional equipment specialist.After several requests, the pt did not provide the serial number of the machine.As a result, a device history record review could not be performed.All device history records (dhr) are reviewed and released according to "dhr review checklist and release procedure".A device is not released if it does not meet requirements or is non-conforming.The pt's biomedical technician reported that there were no problems with the machine.The pt's home therapies rn reported that the pt had no further problems with her treatments following the event.
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Device review: the complaint device is unavailable for investigation.A device history record review was performed which included labeling reconciliation, material/component traceability, non-conformance's and/or any associated rework potentially related to the reported complaint, scrap rates, environmental controls, results on in-process and final qc testing, process controls.The review found the k@home device was manufactured to specifications with no unexpected variances or adjustments.The patient's biomedical technician reported there was no problem with the patient's machine.The patient's rn has reported that treatments have run without any problems since this event.
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