As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that the user performed an in-house abdominal ultrasound scan on a female patient.The user used the 2d b mode and cdv modes for imaging.During the scan, the patient did not say anything about the transducer heating up, thinking that it was normal.Following the procedure, the user wiped off the scanning (b)(6) at the treated area and did not see anything out of the ordinary.When the user spoke with the patient two days later, the patient mentioned a burn had developed on the treated area.On (b)(6) 2017, the user emailed the patient that siemens wanted her to be examined by a medical doctor.The next day, siemens called the patient and the patient reported that she noticed red spots - one the size of a nickel, the other the size of a dime, on her abdomen.One red spot on her upper abdomen midline, just below the xiphoid.The second red spot was on the left lateral side of the abdomen over the region of the spleen.This spot has a small blister in the center.The patient also reported that she has a rash on the left side at the back that was itchy.The patient also stated that she felt no pain after the scan and no pain the following day.A day or two later, siemens requested the patient to go to the clinic.Siemens also called the clinic to let the physician who will be examining the patient that the investigation did not find anything wrong with the transducer.On (b)(6) 2015, the patient has not yet been to the clinic.On (b)(6) 2015, the patient presented to the clinic and she was diagnosed with abdominal wall 1st degree burn.The patient was put on an unspecified medication and was ordered to keep the wound/bandage clean and dry.The patient returned for a follow-up at the clinic on (b)(6)2015 where the physician downgraded the patient's diagnosis to contact dermatitis.The patient was given first aid and was discharged from care on (b)(6) 2015.
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The transducer which is only used in-house was investigated by siemens by measuring the temperature rise on the 6c1hd probe both in-air and on tmm (tissue mimicking material).In the measurement, the investigator searched the temperature rise worst case conditions for b mode and bc mode (cdv mode) and the results showed that the 6c1hd probe, the b-mode in-air temperature rise is 24.3c and tmm temperature rise is 8.5c.The bc-mode in-air temperature rise is 24.7c and tmm temperature rise is 9.4c at the worst case conditions.The aop in-air and on tmm temperature rise regulatory limits are 27c and 10c respectively.The measured temperature rises for 6c1hd probe are below the limits with the sc2000 system.Investigation did not find anything wrong with the ultrasound system and the transducer was reported to be within specifications.The original emdr was submitted to the non-production environment.This report is to submit to the production environment.The original emdr submission is attached.
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