Model Number ACUSON SC2000 |
Device Problems
No Display/Image (1183); Device Operational Issue (2914)
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Patient Problem
No Information (3190)
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Event Date 02/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned/evaluated at a later date, this report will be supplemented.(b)(4).
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Event Description
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It was reported that at the beginning and during an unspecified diagnostic procedure, the ultrasound system intermittently lost the echocardiogram (ecg) trace.The user rebooted the system and the issue was resolved.No additional information was provided.Multiple attempts were made via email to obtain additional information and patient outcome but with no results.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the date received by manufacturer; provide the type of follow-up; provide the type of reportable event; provide the type of follow-up; update the event problem and evaluation codes; and provide additional manufacturer narrative.The device referenced in this report was not returned to siemens for evaluation; however, the system log file was captured and analyzed.During the analysis, it was found two sources that caused the reported issue.The first source is that the ground connection between the common physio module (cpm) and the auxiliary (aux) connector had a small gap that caused the ground not to be properly connected.The second source is that the high frequency noise was coupled to the ground line in the aux cable.These two sources made the cpm more susceptible to electrical noises from sources such as the bovie knife used in the operating room (or).The electrical noise interrupted the communication between the cpm with the rest of the sc2000 system.The root cause of the ultrasound system intermittently losing the echocardiogram (ecg) trace was determined to be the design of the connection of the auxiliary (aux) ecg input of the cpm (cpm recall # z-1200-2018).The reported issue was confirmed based on the results of the ultrasound system log analysis.
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Search Alerts/Recalls
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