MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE

Model Number ACUSON SC2000

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2014

Event Type  malfunction  

Manufacturer Narrative

Customer notified that the hard disk drive can be sent to siemens headquarter support for exam recovery.

Event Description

Tee study was lost during software reload to restore system functionality.

• Brand Name: ACUSON
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA INC.; mountain view CA 94043
• Manufacturer Contact: karen smith, vp ; 685 east middlefield road; business unit ultrasound; mountain view, CA 94043 ; 8004228766
• MDR Report Key: 5485679
• MDR Text Key: 39978588
• Report Number: 3009498591-2015-00094
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 072786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1