MAUDE Adverse Event Report: SIEMENS ACUSON X300; ULTRASOUND MACHINE

Model Number 08648037

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/23/2015

Event Type  malfunction  

Event Description

A boxed message came up that said something like "machine shutting down to prevent permanent damage to system".Then the machine shut itself off.The patient was under anesthesia on an operating room table when it happened and the procedure had to be aborted.The machine also failed on two other occasions within the same month.

• Brand Name: ACUSON X300
• Type of Device: ULTRASOUND MACHINE
• Manufacturer (Section D): SIEMENS; 685 east middlefield road; mountain view CA 94043
• MDR Report Key: 5055973
• MDR Text Key: 24996967
• Report Number: 5055973
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 08648037
• Device Catalogue Number: 08648037
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1