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

Model Number Z6MS TRANSDUCER

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/22/2017

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.

Event Description

This incident is being submitted as a medical device report (mdr) because the reported incident describes areas of discoloration within the esophagus following a trans-esophageal echocardiography examination.The incident was reported as a "heat injury".A request for the product to be returned has been initiated.When the investigation is completed, or otherwise additional information relative to the safety classification is learned, a supplemental report will be filed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information and provide the date new information was received.The results of the investigation will be provided in a supplemental mdr.

Event Description

Additional information was received from the user facility in (b)(6) and it was reported that siemens checked with the physician who performed the transesophageal echocardiography (tee) procedure.According to the physician, the patient may have had an unknown pre-existing condition prior to the tee.The physician felt this could also be a cause of the lesions on the throat.The patient was given the medication nexium after the examination.This medication is primarily used to treat gastroesophageal reflux disease (gerd).It can also lower the risk of bleeding after endoscopy in patients with ulcers.Because of this, it is thought that this patient may have had other health related issues which contributed to the presence of the throat lesions.It has been confirmed the patient did not have any lasting effects from the throat lesions.The hospital continued to use the transducer.We have collected this transducer for investigation and provided the customer with a new replacement.

Manufacturer Narrative

This supplemental report is being submitted to update the device available for evaluation, provide the date the new information was received, update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the device evaluation results.The device referenced in this report was returned to siemens for evaluation.The device was visually inspected and there were no physical damage or anomalies observed.Engineering conducted a system test and there were no system errors produced.The transducer's acoustic properties were tested and there was no evidence of overheating.Based on the test results, the transducer was still within its specified limit and it was concluded that it was not the causal or the likely contributor to the alleged transesophageal lesions.In conclusion, there was no device failure detected and the transducer performed as intended and within specifications.

• 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 4050
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4252709862
• MDR Report Key: 6968864
• MDR Text Key: 90221828
• Report Number: 3009498591-2017-00441
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• 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