MAUDE Adverse Event Report: GE HEALTHCARE AUSTRIA GMBH & CO OG ULTRASOUND TRANSDUCER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number RAB6-D

Device Problems Energy Output Problem (1431); Unexpected Therapeutic Results (1631)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

During a routine ob exam for ultrasound, 3d/4d was used by sonographer.During this she and the patient felt a buzz from the probe.It was a question of shock versus vibration, described as a weird sensation.No one was harmed at the time and the scan was able to be completed.The probe was removed from the machine and biomed was called.Manufacturer response for ultrasound transducer, (brand not provided) (per site reporter).The probe was swapped out.

• Brand Name: ULTRASOUND TRANSDUCER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): GE HEALTHCARE AUSTRIA GMBH & CO OG; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 14914524
• MDR Text Key: 295256156
• Report Number: 14914524
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: RAB6-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1