MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON 18L6 ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number 18L6 TRANSDUCER

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to siemens for evaluation.During investigation, it was found an image artifact and the chips had overheated, confirming the reported complaint.These were due to a coax cable damage noted during the evaluation.The possible root cause of the reported complaint was due to chip damage or electrical short.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.This report is resubmitted on request by the fda.

Event Description

It was reported that the user was performing an ordinary inspection during patient planning when the transducer was noted to be overheating.The user replaced the transducer to continue and complete the unspecified study.There was no need to repeat the study because the reported phenomenon occurred prior to the start of procedure.There was no user or patient injury reported.No additional information was provided.

• Brand Name: ACUSON 18L6 ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view, ca
• Manufacturer Contact: christine dunn ; 22010 se 51st st; issaquah, wa ; 7851617
• MDR Report Key: 6525563
• MDR Text Key: 199700485
• Report Number: 3009498591-2017-00063
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18L6 TRANSDUCER
• Device Catalogue Number: 10789400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2017
• 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
• Patient Sequence Number: 1