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

Model Number ACUSON X300 PE, 100V/115/230V 17FPD

Device Problem Mechanics Altered (2984)

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

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

System lock up while v5m was connected.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: 5810999
• MDR Text Key: 50755152
• Report Number: 3009498591-2016-00236
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON X300 PE, 100V/115/230V 17FPD
• Device Catalogue Number: 10566144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• 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