It was reported that after the patient was sedated, the patient underwent an unspecified procedure.During the procedure, the physician was observing the mitral valve with a 2d transesophageal echocardiography (tee) transducer when it was observed that the image looked like the 2d image gain had dropped.The ultrasound system was rebooted; however, it was replaced with another system to complete the procedure.The tee transducer was also replaced.There was a delay of 10 minutes while the equipment were prepared.There was no loss of data and there was no patient adverse event reported.No additional information was provided.
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The device referenced in this report was returned to siemens for evaluation.During visual inspection, the investigator found a bite mark at the transducer tip.A system test was conducted and an image distortion was observed.Acoustic performance and interconnectivity tests have failed; however, the factory leakage test passed at full level.The investigator analyzed the cable and found that the vtgc+~gnd net cable short (16.4~17.0 ohm) was bent at the strain relief area.This caused an electrical short fault that caused the image problem which could also produce an intermittent system error.Based on the test results, the root cause of the reported complaint was determined to be reliability manufacturing issue at the supplier.The process was improved by supplying the 2 wires directly and individually, rather than coiling them together, to bundle the twinax shield in the co-axial cable.This, thereby increased the mechanical strength of the cable and improved reliability.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.Reference complaint # (b)(4).
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