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

Model Number INSIGHT FD

Device Problems Defective Component (2292); Unexpected Shutdown (4019)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

Equipment stopped working intraop.Mini c-arm hologic stopped working mid-procedure.Giving message of error.Manufacture rep notified.Local xray department notified.Increase length of the surgical procedure as a result.Mini c-arm moved for cases scheduled (main or can use regular c-arm).Company tech checked unit and ordered needed parts.Rn biomed : device is under warranty, oem hologic notified and parts are on order.Manufacturer response for x-ray, c-arm, (brand not provided) (per site reporter).Fse removed and replaced a new source, part/# rm-asy-08339, power supply and performed the required calibrations system checked and tested o.K.

• Brand Name: FLUOROSCAN INSIGHT MINI C-ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): HOLOGIC INC.; 600 technology drive; newark DE 19702
• MDR Report Key: 15515953
• MDR Text Key: 300908091
• Report Number: 15515953
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2022,07/21/2022

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
• 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: 09/21/2022
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: Asian