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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 No Patient Involvement (2645)
Event Date 03/14/2017
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has not been returned to siemens for evaluation. If additional information is received or if the device is returned at a later date, this report will be supplemented.
 
Event Description
It was reported that the transducer generated a temperature error during system check/equipment testing. There was no study being performed or patient involvement when the reported phenomenon occurred. No additional information was provided.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional manufacturer narrative. After multiple attempts to obtain information about the sn and disposition of the transducer, no response was received. This complaint is therefore, being close to likely cause of gastro flex control traces crack based on trending data.
 
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Brand NameACUSON Z6MS ULTRASOUND TRANSDUCER
Type of DeviceULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view CA 94043 4050
Manufacturer Contact
scott christiansen
685 east middlefield road
mountain view, CA 94043-4050
4255571625
MDR Report Key6458138
MDR Text Key71737550
Report Number3009498591-2017-00148
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2017
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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