MAUDE Adverse Event Report: HOLOGIC INC INSIGHT 2; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number INSIGHT 2

Device Problems Fire (1245); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2018

Event Type  malfunction  

Event Description

Biomed was called to the repair a c-arm at a remote clinic.We identified that the power supply was faulty.After investigating what on the power supply failed, we opened up the metal case of the power supply.(by force as this is not a case meant to be opened.) we found the battery had caught fire.(picture attached to this report) we called the vendor and asked if this battery was meant to be replaced.They stated it was not part of a pm.It served as a backup in case of power loss, much like a ups.Our unit was approximately 5 years old.

• Brand Name: INSIGHT 2
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): HOLOGIC INC; 250 campus dr; marlborough MA 01752
• MDR Report Key: 7376839
• MDR Text Key: 103676348
• Report Number: 7376839
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: INSIGHT 2
• Other Device ID Number: XRY0358
• 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: 03/23/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO