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); Loss of Data (2903); Device Operational Issue (2914)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 03/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned at a later date, this report will be supplemented.(b)(4).

Event Description

It was reported that the z6ms transducer was generating an over-temperature shutdown when used with the sc2000 ultrasound system.The doctor was performing a tee procedure with the tube inside the patient , while the patient was under sedation.The event occurred at the beginning of the procedure.The system was rebooted, and the procedure completed with the same ultrasound system.Completion of the procedure was delayed by 6 minutes.Additional sedation was administered to the patient as a result of the delay.There was no patient injury as a result.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide patient information.(b)(4).

Event Description

The transducer was replaced and because there was loss of data, the transesophageal echocardiography (tee) exam was repeated.

Manufacturer Narrative

This supplemental report is being submitted to update the device available for evaluation; provide the date new information was received and provide the type of report; provide the type of reportable event, provide the type of follow-up, update the device evaluated by manufacturer, and update the event problem and evaluation codes and provide the device evaluation results.Based on the initial investigation done by the customer service engineer (cse), it was presumed that the issue was related to the z6ms transducer malfunction.However, the cse later confirmed that there was no transducer issue and it was not replaced at the site.The transducer engineer confirmed that the cse testing method used on the site to measure transducer temperature was incorrect - a water bath at the specific temperature did not equate to the temperature reported by the probe.The cse later replaced the rad board and mpi board, which got the system up and running.The rad board and mpi board were returned for investigation.The supplier investigated the mpi board and could not reproduce the issue.The supplier also tested the returned rad board, and found two heat sinks used for u64 and u53 were not as secure as they should be.However, those loose heat sinks would not explain why the z6m over temperature shutdown occurred.Thus, the investigational results are inconclusive and the root cause of the reported issue could not be determined.Reference complaint # (b)(4).

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043
• MDR Report Key: 7419766
• MDR Text Key: 105440976
• Report Number: 3009498591-2018-00012
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR