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

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

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.

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).

• 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
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4255571625
• MDR Report Key: 6603139
• MDR Text Key: 76438386
• Report Number: 3009498591-2017-00219
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K130881
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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: 10855905
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 20