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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON V7M ULTRASOUND TRANSDUCER ULTRASOUND DEVICE

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON V7M ULTRASOUND TRANSDUCER ULTRASOUND DEVICE Back to Search Results
Model Number V7M TRANSDUCER
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the log files were reviewed, and it was confirmed that the system and transducer were working as specified. When probe temperatures increase to defined thresholds, the system is responding as expected. Complaint reference #: (b)(4).
 
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 after a (b)(6) year old patient was sedated, the patient underwent a ventricular septal defect (vsd) repair procedure. During the procedure, the transducer temperature was at 39ºc before it was inserted into the patient. After the physician inserted the transducer, the temperature increased to 43ºc and the imaging has been suspended. The physician disconnected the transducer and plugged it in and out a few times but still exhibited the same phenomenon. The transducer was removed and the ultrasound system was rebooted. A similar transducer was reinserted into the patient to continue and successfully complete the procedure. There was a delay of 30 minutes due to the troubleshooting and prepping the replacement transducer. There was no loss of data and there was no patient adverse event reported. No additional information was provided.
 
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Brand NameACUSON V7M ULTRASOUND TRANSDUCER
Type of DeviceULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view CA 94043 4050
MDR Report Key6993204
MDR Text Key290785135
Report Number3009498591-2017-00471
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,foreig
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV7M TRANSDUCER
Device Catalogue Number8664703
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

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