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

Model Number ACUSON SC2000

Device Problem Mechanics Altered (2984)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleged system lock up.The investigation is in process.

• Brand Name: ACUSON
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain vew CA 94043 4050
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain vew CA 94043 4050
• Manufacturer Contact: karen smith ; 685 east middlefield road; mountain view, CA 94043-4050
• MDR Report Key: 5700879
• MDR Text Key: 47851457
• Report Number: 3009498591-2016-00159
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• 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: 10041461
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1