MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS ACUSON ANTARES CH5-2 TRANSDUCER; ULTRASOUND DEVICE

Model Number CH5-2 TRANSDUCER

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Shock (2072); Electric Shock (2554)

Event Date 04/06/2017

Event Type  Injury  

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 the reported that a female patient who is pregnant and the usual user of the device at the user facility underwent an obstetric scan performed by another doctor.During the procedure, the patient and the doctor started to feel electrical shocks that was reported to generate from the transducer; however, the procedure was completed with no equipment changes.There was no loss of data so the scan was not repeated.No additional information was provided.

Manufacturer Narrative

Investigation: the device referenced in this report was returned to siemens for investigation.This complaint was investigated for the event where the patient and user felt electric shocks while using ch6-2 transducer.The initial report was submitted on model# ch6-2 transducer, with serial number (b)(4), but engineering confirmed that this serial number is for a ch5-2 transducer.Thus, this information in being corrected in the report.The defective transducer was not returned as a complaint part and therefore, was scrapped without engineering evaluation.Thus, an investigation for root cause determination of the issue could not be performed.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.Complaint reference #: (b)(4).

• Brand Name: SIEMENS ACUSON ANTARES CH5-2 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: 6525747
• MDR Text Key: 73825638
• Report Number: 3009498591-2017-00175
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K063803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH5-2 TRANSDUCER
• Device Catalogue Number: 08648086
• 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: 04/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2010
• 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 Outcome(s): Other