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

Model Number SC2000

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the customer decided not to have the system serviced by siemens, and therefore no system log files could be retrieved to further investigate the issue.With limited available information, the cause of the issue cannot be determined.Reference: (b)(4).

Event Description

On (b)(6) 2019 an acuson sc2000 system was used for a non-operative transesophageal echocardiogram (tee) study with a v5ms transducer.The doctor stated he had taken the system to endoscopy, and performed the tee on the patient.During the study he heard beeps for each 6 second clip.He completed the study, returned to the department, and plugged it into the network.When he looked the next day, only the patient header information was there.No images, clips or thumbnails were in the system.According to the submitter, the data could not be recovered, and the study will have to be repeated.There was no injury to the patient.

• Brand Name: ACUSON SC2000
• Type of Device: ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2500 millbrook drive; buffalo grove IL 60089
• Manufacturer Contact: christine dunn ; 22010 se 51st st; issaquah, WA 98029 ; 4257851617
• MDR Report Key: 8525509
• MDR Text Key: 142407877
• Report Number: 3009498591-2019-00004
• Device Sequence Number: 1
• Product Code: IYN
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR