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

Model Number SEQUOIA C512 CARDIO

Device Problem Computer Software Problem (1112)

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

Event Date 12/17/2013

Event Type  malfunction  

Manufacturer Narrative

Investigation found that the system would not boot up.Performed back up and installed system software.

Event Description

After completing a tee exam in a lab, the customer powered down the system and moved it to their network transfer room.System then failed to boot all the way to imaging.Software had to be reloaded.As a result a patient exam was lost and therefore had to be repeated.

• 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: 5607650
• MDR Text Key: 43765407
• Report Number: 3009498591-2015-00129
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 052331
• 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: Replace
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEQUOIA C512 CARDIO
• Device Catalogue Number: 08267697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2004
• 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