MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S2000

Device Problems Poor Quality Image (1408); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: the device referenced in this report has not been returned to siemens for evaluation.If the device is received at a later date, this report will be supplemented.Follow-up narrative: relevant tests/other relevant history: not applicable, no adverse event.Implant/explant date: not applicable, not an implant.Device manufacture date: not available.Investigation: the complaint was investigated for bad resolution at exams, and transducers heating in abnormal conditions.The unit was never received at the factory.Per order management, the rma was cancelled, and the country/customer is keeping the system.The unit is not currently planned to be returned for failure analysis.There is insufficient information provided by the complainant to determine root cause.Speculation on root cause could be a failure in the thermal protection in the transducer and the system.However these are monitored by the rc board in the system, and the voltages used in transmission are monitored by fptop process controls and will shutdown if there is any difference in the power output.This unit was retained by the country, and was not returned for failure analysis.This was a customer education issue; no further follow up was noted after the request for actual thermal measurements of the probe were requested, but not received).Complaint reference #: (b)(4).

Event Description

It was reported that during equipment testing for a routine but unspecified exam, the transducer became very hot and the image quality was reported to be bad.The report stated that the issue was intermittent and the transducer did not warm up at first so temperature measurement was performed.When the temperature reached approximately 34 degrees, the system hang up and a us_img_29 and 20 error messages were displayed.The exam was delayed because the user had to make adjustments to the image quality.Although there was no loss of data, the exam was repeated when the system was restarted.There was no patient adverse event reported.No additional information was provided.

• Brand Name: ACUSON S2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• Manufacturer Contact: khalil thomas ; business area ultrasound; 22010 se 51st street; issaquah, WA 98029 ; 4253929180
• MDR Report Key: 7285886
• MDR Text Key: 274944224
• Report Number: 3009498591-2017-00083
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K140959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON S2000
• Device Catalogue Number: 10041461
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2018
• 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