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

Model Number ABVS-BASE BOM

Device Problem Fracture (1260)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

While setting up the abvs system for a trade show, the service engineer noticed a bad weld on the outward most arm.The break started from the bottom, suggestive of transport damage.Due to the characteristics of the crack (bottom up), it appears to be caused by insufficient packaging to transport as opposed to top down crack where the applied pressure from clinical use.No consequences to the pt or user were reported.Upon further investigation, it was discovered that the welding cracked across the entire circumference of the joint causing the arm to no longer be attached to the circular joint.

Manufacturer Narrative

The root cause investigation revealed that our vendor changed welding suppliers without notification to siemens.The siemens' specifications were not met, as the new supplier was grinding down the welds, compromising the weld strength.

• 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 ; 685 east middlefield road; business unit ultrasound; mountain view, CA 94043 ; 8004228766
• MDR Report Key: 4349549
• MDR Text Key: 5205175
• Report Number: 3009498591-2014-00039
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 081148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABVS-BASE BOM
• Device Catalogue Number: 10434730
• Other Device ID Number: 10434730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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