MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON VF10-5 ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number VF10-5 TRANSDUCER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Shock (2072)

Event Date 07/05/2017

Event Type  Injury  

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

It was reported that the technologist was halfway through the left lower extremity venous duplex study and imaging behind the left knee, when the patient experienced a shock.The technologist checked the probe with her finger but could not feel any sharp edges nor could feel electrical current along the face and edges of the probe.The technologist resumed scanning and almost immediately the patient yelped again, stating that it was definitely a jolt.The technologist tried the third time and the patient yelped and jerked her leg away, stating that she felt a jolt from her knee traveling up to her thigh almost to her groin.The technologist used a curved probe to double check the patients' deep calf veins, and the patient did not experience any discomfort with the curved probe.There was no permanent injury to the patient, no redness or areas of abrasion or evidence of a burn.No treatment for injury was required on her leg as a result of the complaints she experienced during the duplex scan.The system was not rebooted.The procedure was completed despite the patient's complaint, using both the linear probe in question and the curved (c-4) probe.The study images do not show anything regarding what the patient felt.There was no loss of data and the study did not have to be repeated.No additional information was provided.

Manufacturer Narrative

Investigation: the complaint was investigated for the vf10-5 transducer shocking a patient during a vascular scan.The transducer was returned and tested, but the reported issue could not be reproduced.All the manufacturing testing passed; the reported issue could not be identified.

• Brand Name: ACUSON VF10-5 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 ; 4255571625
• MDR Report Key: 6751566
• MDR Text Key: 81319256
• Report Number: 3009498591-2017-00324
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VF10-5 TRANSDUCER
• Device Catalogue Number: 10658844
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 159