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

Model Number Z6MS TRANSDUCER

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Mechanical failure while articulating the tip of the transducer.

• Brand Name: ACUSON
• Type of Device: DIAGNOSTIC ULTRASOUND DEVICE
• 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.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: karen smith ; 685 east middlefield road; mountain view, CA 94043-4050 ; 8004228766
• MDR Report Key: 5603596
• MDR Text Key: 44204502
• Report Number: 3009498591-2016-00078
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 072786
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z6MS TRANSDUCER
• Device Catalogue Number: 10436113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2015
• 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