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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE Back to Search Results
Model Number Z6MS TRANSDUCER
Device Problem Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 01/02/2016
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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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Brand NameACUSON Z6MS ULTRASOUND TRANSDUCER
Type of DeviceULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
business area ultrasound
22010 se 51st street
issaquah WA 98029
MDR Report Key6407180
MDR Text Key283507177
Report Number3009498591-2016-00457
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K142628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZ6MS TRANSDUCER
Device Catalogue Number10436113
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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