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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 Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the complaint was investigated for overheat (43 degree celsius) message appearing on monitor with v7m. In this case, a review of the log files confirmed that both the system and the transducer were working as specified. It is recommended that local applications support work with the users on optimal thermal management of v7m transducer during clinical use. The transducer operated as specified, and there was no product malfunction. 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 a (b)(6) pediatric patient who was already sedated and ventilated was undergoing a transesophageal echocardiography (tee) procedure to repair a ventricular septal defect. In the middle of the procedure, while the doctor was performing the tee, an "overheat" (43 degree celsius) message appeared on the monitor. The doctor removed the transducer and rebooted the system. The procedure was completed without a tee probe. The procedure was not repeated because there was no loss of data. 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
Manufacturer Contact
scott christiansen
685 east middlefield road
mountain view, CA 94043-4050
4255571625
MDR Report Key6603139
MDR Text Key185846048
Report Number3009498591-2017-00219
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K130881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV7M TRANSDUCER
Device Catalogue Number10855905
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2015
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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