Model Number Z6MS TRANSDUCER |
Device Problem
Device Displays Incorrect Message (2591)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/13/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 at a later date, this report will be supplemented.(b)(4).
|
|
Event Description
|
It was reported that during patient planning and prior to a transesophageal echocardiography (tee) procedure, the transducer generated a usacquisitionhw_31 error message.The patient was already under anaesthesia when the error was displayed.The ultrasound system was not rebooted but it was replaced with a different but similar system.The transducer was also replaced to continue and complete the tee.The procedure was delayed by 20 minutes while the replacement devices were prepared.There was no patient adverse event reported.No additional information was provided.
|
|
Manufacturer Narrative
|
Investigation: the complaint was investigated for an acquisition 31 error code.The transducer was returned, and an investigation was performed.Engineers were able to reproduce the acquisition 31 error.The cause of the issue was determined to be a gastro flex thermistor reliability issue; this is related to design.Improvements to the gastro flex trace were implemented into forward production, since july 2017.The transducer returned from the customer site was manufactured prior to the corrective action.Complaint reference #: (b)(4).
|
|
Search Alerts/Recalls
|