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

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

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.

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).

• Brand Name: ACUSON V7M ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• MDR Report Key: 6993204
• MDR Text Key: 91498687
• Report Number: 3009498591-2017-00471
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V7M TRANSDUCER
• Device Catalogue Number: 8664703
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR