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

Model Number ACUSON SC2000

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

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 in the middle of a patient echocardiography stress (ecg) test, it was observed that the ecg signal became intermittent.The user rebooted the ultrasound system and the ecg was subsequently completed.Reportedly, the test was delayed by five minutes due to the reboot and there was no bovie knife nearby during the test.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

H3: updated, h6: updated codes for the evaluation results.Evaluation summary: the system log files were reviewed by engineering, which attributed the continuous watchdog time-out error to an internal cpm (hardware) error.The cpm was analyzed by the supplier, and the reported issue could not be reproduced, however.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: 8038640
• MDR Text Key: 127896891
• Report Number: 3009498591-2018-00042
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1