MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION / VOLCANO CORPORATION IVUS MACHINE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem No Display/Image (1183)

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

Event Date 08/07/2022

Event Type  Injury  

Event Description

During tevar the ivus machine lost the picture.Several tech's attempted to troubleshoot and equipment rep attempted to troubleshoot via phone without success.The decision was made to stop the procedure.

• Brand Name: IVUS MACHINE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION / VOLCANO CORPORATION
• MDR Report Key: 15589082
• MDR Text Key: 301727244
• Report Number: MW5112556
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male