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

Model Number ACUSON SC2000

Device Problems Loss of Data (2903); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

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.(b)(4).

Event Description

It was reported that a patient was in the middle of undergoing a stress echo exam when the echocardiogram (ecg) flat-lined; however, it came back before the exam ended.The same transducer and ultrasound system were used to complete the ecg.Then it was found that the ecg images were lost.The ecg was repeated five hours later.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the new date additional information was received (see section g4); provide the type of report (see section g7); provide the type of follow-up (see section h1); and provide the investigation results (see h10).The defective cable was scrapped and was not returned to siemens for evaluation; however, the savelogs were captured.The service engineer analyzed the savelogs and found no issues related to the reported event and the symptoms were reported to be intermittent.The likely probable cause of the report of losing echocardiogram (ecg) signal was due to poor connection between the aux cable and the cable from the external stress machine.Reference: (b)(4).

• Brand Name: ACUSON SC2000 ULTRASOUND SYSTEM
• 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: 7423232
• MDR Text Key: 105518028
• Report Number: 3009498591-2018-00013
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K113179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1