MAUDE Adverse Event Report: HOLOGIC, INC. FLOUROCSAN INSIGHT MINI C ARM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number INSIGHT FD

Device Problems Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

When doctor attempted to use, a failure message popped up on screen: " image processor failed to start image acquisition.Please stop x-ray actuation." mini c powered down x2, attempted to use again x2.Converted to use of large c arm machine.

• Brand Name: FLOUROCSAN INSIGHT MINI C ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 16311056
• MDR Text Key: 308925062
• Report Number: 16311056
• Device Sequence Number: 1
• Product Code: OXO
• 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: 01/30/2023

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: Health Professional
• Device Model Number: INSIGHT FD
• Device Catalogue Number: SW005324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA