MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYTEM; ULTRASOUND DEVICE

Model Number ACUSON SC2000

Device Problems Application Program Problem (2880); Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to siemens for evaluation.A supplemental mdr will be submitted if more information is received.(b)(4).

Event Description

It was reported that a (b)(6)-year old female patient who was experiencing chest pain underwent a dobutamine stress echocardiogram as a pre-op to rule out coronary heart disease.During the test, the patient was given dobutamine to stimulate and increase her heart for the stress portion of the test.After the procedure was completed, it was found that the images were not transferred and became lost.Since the test was positive for a coronary artery disease, the doctor who was watching the test, did not want to re-administer the dobutamine to repeat the stress test for the patients' safety.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

Investigation summary: the system log files were reviewed by engineering, and the lost ultrasound images were attributed to a software error, in which different potential boot up sequences prior to image acquisition were not accounted for.When the system boot up sequence is different than the standard sequence expected in the code, it prevents imaging from receiving a state change event to allow a communication channel setup.Captures done in acquisition are then never sent to review, which prevents the user from selecting and saving the images during a stress echo exam.This issue was fixed with a code change released in software version vb21b.Reference: (b)(4).

• Brand Name: ACUSON SC2000 ULTRASOUND SYTEM
• 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: 8052982
• MDR Text Key: 126657971
• Report Number: 3009498591-2018-00043
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K132654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON SC2000
• Device Catalogue Number: 10433816
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOBUTAMINE
• Patient Age: 69 YR
• Patient Weight: 95