MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS IE33; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number IE33

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

Patient stated that ultrasound probe felt like it was shocking, poking him.I immediately stopped using the probe.Put transducer out of commission, tagged, notified supervisor, manager and ultrasound company.I finished the exam with a separate probe without any feeling that probe was shocking or poking him.

• Brand Name: IE33
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MN *
• MDR Report Key: 4764899
• MDR Text Key: 5784253
• Report Number: 4764899
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: IE33
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2015
• Patient Sequence Number: 1
• Patient Age: 78 YR