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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 Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2015
Event Type  malfunction  
Manufacturer Narrative
Original submission narrative: the transducer was returned to siemens for evaluation. During visual inspection, investigation found a dent at the nosepiece area and it was noted that the articulation sleeve was cracked. It is believed that these phenomenons were created from the outside by some physical force. Destructive analysis showed no cuts on the shield braids. 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 device investigation, a dent was found on the nosepiece. A crack on the articulation sleeve was found, which appears to have been cause by an external force. Therefore, the most probable cause is due to customer misuse. It was recommended to the customer to handle the transducer carefully. Note: the original emdr was submitted to the non-production environment. This report is to submit to the production environment. Original files are attached. This emdr contains both the initial submission and fu#2 (fu#1 could not be located).
 
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 a hole in the articulating sleeve was noted during leakage current test and before the start of the procedure. There was no patient involvement. No additional information was provided.
 
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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 Key6312911
MDR Text Key270997238
Report Number3009498591-2016-00401
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,user f
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 Received02/08/2017
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 Manufacturer01/20/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2015
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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