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

Model Number ACUSON SC2000

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 10/11/2013

Event Type  malfunction  

Manufacturer Narrative

The brake linkage connections was not secured with loctite per the assembly drawing note.Rework all in-process and finished goods in-house was performed and verified.

Event Description

During in-house inspection, incorrect assembly of the caster control swivel rod was observed.

• Brand Name: ACUSON
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA INC.; mountain view CA 94043
• Manufacturer Contact: karen smith vp, regulatory affa ; 685 east middlefield road; mountain view, CA 94043 ; 8004228766
• MDR Report Key: 5607659
• MDR Text Key: 44197655
• Report Number: 3009498591-2015-00065
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 072786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• 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: 10433816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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