SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE
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Model Number Z6MS TRANSDUCER |
Device Problem
Temperature Problem (3022)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Original submission narrative: the transducer referenced in this report was returned to siemens for evaluation.During visual inspection, it was found two small dents at the articulation sleeve knuckle area.A hipot leakage test was performed but it failed due to pin holes found on the articulation sleeve.A destructive test was conducted and investigation found that there was no shield braid cut or physical damage; however, a burn was observed on the braid.This is attributable to the hipot test.The reported temperature error was unable to be reproduced, but the c-flex articulation sleeve material is suspicious because of particle or foreign substance.Liquid could infiltrate into the articulation sleeve pin hole which may cause electrical malfunction which can lead to system error.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.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation , update the follow-up type , update the device evaluated by manufacturer , update the event problem and evaluation codes , and provide the investigation results.Investigation: during the investigation of the complaint, it was determined that the possible root cause of the system error message was due to the quality of the articulation sleeve material.A hole in the articulation sleeve led to liquid infiltration into the sleeve.Through a capa, an articulation sleeve material inspection & rework was initiated in november 2015, and a new sleeve material change was implemented in september 2016.This defective transducer was prior to the corrective action.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.All original files are attached.This emdr contains both the initial and fu#1.
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Event Description
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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 during an unspecified procedure, the customer informed siemens that while the transducer was initializing, the temperature limit was reached and generated an overtemp message (error 35).No additional information was provided.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of the potential adverse event before we have received patient outcome information.Unfortunately, due to the aware date, this information is not readily available and we are making every effort to obtain this information.Should we receive further information in regards to this event, we will file a follow-up report.
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Search Alerts/Recalls
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