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

Model Number SC2000

Device Problem Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

The device is undergoing an evaluation but has not yet been completed.

Event Description

Alleged loss of data.The investigation is in process.

• Brand Name: SIEMENS ACUSON SC2000
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043 ; 6509699112
• MDR Report Key: 6012700
• MDR Text Key: 57305791
• Report Number: 3009498591-2016-00487
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC2000
• Device Catalogue Number: 10433816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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