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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 Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2017
Event Type  malfunction  
Manufacturer Narrative
Original submission narrative: this issue is under investigation. A follow-up report will be submitted when the investigation results are available. 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 was from gastro flex thermistor trace crack and open due to insufficient cable assembly and/or gastro flex reliability; these are related to design. Appropriate improvement action plans were established through a capa.
 
Event Description
It was reported that the transducer probe registered an "overheat" error code just after it was inserted into the patient during a transesophageal echocardiography (tee) procedure. The reported phenomenon locked up the ultrasound system so a replacement probe was brought in to continue and complete the tee. There was a short delay while the new probe was obtained. There was no need to repeat the procedure because there was no loss of data. There was no patient injury reported. 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 Key6402566
MDR Text Key280685060
Report Number3009498591-2017-00037
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 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2017
Was Device Evaluated by Manufacturer? Yes
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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