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

Model Number ACUSON SC2000

Device Problems Circuit Failure (1089); Temperature Problem (3022); Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to siemens for evaluation.This mdr will be supplemented if additional information is received.Reference complaint # (b)(4).

Event Description

It was reported that while a patient was in the middle of undergoing a stress echo study, the ultrasound system periodically froze.The user rebooted and restarted the system several times and this resulted in delay in completing the study.It was also observed that the fans were running high.This may explain the reason why the system was freezing.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

Evaluation summary: the rad9 board associated with the reported event was scrapped, thus, no failure analysis of the part could be done.Review of the log files from the system was performed by engineering, and they indicate a hw component failure in the rad9 board, but the analysis results are inconclusive, as the part could not be analyzed.The rad board was replaced at the site for this issue.Reference complaint: (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: 8120121
• MDR Text Key: 128905859
• Report Number: 3009498591-2018-00045
• 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
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• 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?: Yes
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1