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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, PRODUCT CODE: ITX

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE, PRODUCT CODE: ITX Back to Search Results
Model Number Z6MS
Device Problems Collapse (1099); Mechanical Problem (1384)
Patient Problem Ulceration (2116)
Event Date 12/18/2018
Event Type  malfunction  
Manufacturer Narrative
This mdr will be supplemented if additional information is received. Reference complaint # (b)(4).
 
Event Description
It was reported that an "in patient" underwent a trans-esophageal echocardiography (toe) procedure. During the procedure, the transducer folded over on itself inside the patient's esophagus. The transducer was inserted 10-15 cm without an issue. It was then noted that the image was inverted. Because there was no trouble when inserting the transducer it was further advanced into the stomach where normal manipulation was attempted. It was confirmed via x-ray that the transducer had folded over. The med team took the patient to icu and used a pediatric endoscope under sedation to examine the transducer and remove it - no surgery required. During the endoscope procedure a sub mucosal ulceration was observed, however, no perforation was observed. There was no injury reported. The patient was discharged to the ward two days later. No additional information was provided.
 
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Brand NameACUSON Z6MS ULTRASOUND TRANSDUCER
Type of DeviceULTRASOUND DEVICE, PRODUCT CODE: ITX
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view CA 94043 4050
Manufacturer Contact
christine dunn
685 east middlefield road
mountain view, CA 94043-4050
4257851617
MDR Report Key8237710
MDR Text Key134493688
Report Number3009498591-2019-00001
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K142628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZ6MS
Device Catalogue Number10436113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2017
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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