It was the reported that a female patient who is pregnant and the usual user of the device at the user facility underwent an obstetric scan performed by another doctor.During the procedure, the patient and the doctor started to feel electrical shocks that was reported to generate from the transducer; however, the procedure was completed with no equipment changes.There was no loss of data so the scan was not repeated.No additional information was provided.
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Investigation: the device referenced in this report was returned to siemens for investigation.This complaint was investigated for the event where the patient and user felt electric shocks while using ch6-2 transducer.The initial report was submitted on model# ch6-2 transducer, with serial number (b)(4), but engineering confirmed that this serial number is for a ch5-2 transducer.Thus, this information in being corrected in the report.The defective transducer was not returned as a complaint part and therefore, was scrapped without engineering evaluation.Thus, an investigation for root cause determination of the issue could not be performed.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.Complaint reference #: (b)(4).
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