MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS ACUSON S2000 6C1 ULTRASOUND TRANSDUCER

Model Number 6C1 HD TRANSDUCER

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to siemens for evaluation; therefore, the investigation of the device could not be performed and the cause of the reported phenomenon could not be conclusively determined.

Event Description

It was reported that during an abdominal procedure, it was noted that the lens material had separated from the plastic housing of the 6c1 transducer.The procedure was completed with the same device.It was not necessary to repeat the procedure since the data was not lost.There was no patient or user injury reported.No additional information was provided.

• Brand Name: SIEMENS ACUSON S2000 6C1 ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043 ; 4255571625
• MDR Report Key: 6126513
• MDR Text Key: 60873443
• Report Number: 3009498591-2016-00623
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6C1 HD TRANSDUCER
• Device Catalogue Number: 10135941
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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