MAUDE Adverse Event Report: COMMUNICATIONS & POWER INDUSTRIES CANADA, INC; GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC

Model Number VZW2556RC3-65

Device Problem Failure to Capture (1081)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 05/18/2019

Event Type  malfunction  

Event Description

Patient was radiated twice due to equipment failure.Initial images could not be captured and had to be repeated.

• Type of Device: GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC
• Manufacturer (Section D): COMMUNICATIONS & POWER INDUSTRIES CANADA, INC; 5865 wedgewood drive; granite bay CA 95746
• MDR Report Key: 8707260
• MDR Text Key: 148283574
• Report Number: 8707260
• Device Sequence Number: 1
• Product Code: IZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VZW2556RC3-65
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1460 DA