MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number Z6MS TRANSDUCER

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

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

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: this issue is under investigation.A follow-up report will be submitted when the investigation results are available.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type,update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.Investigation: during the investigation of the complaint, it was determined that the possible root cause of the system error was from gastro flex thermistor trace crack and open due to insufficient cable assembly and/or gastro flex reliability; these are related to design.Appropriate improvement action plans were established through a capa.

Event Description

It was reported that the transducer probe registered an "overheat" error code just after it was inserted into the patient during a transesophageal echocardiography (tee) procedure.The reported phenomenon locked up the ultrasound system so a replacement probe was brought in to continue and complete the tee.There was a short delay while the new probe was obtained.There was no need to repeat the procedure because there was no loss of data.There was no patient injury reported.No additional information was provided.

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• 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: 6402566
• MDR Text Key: 280685060
• Report Number: 3009498591-2017-00037
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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