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

Model Number INSIGHT FD

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2022

Event Type  Injury  

Event Description

Mobile c arm was being used in a case and the monitor arms snapped off of the base and almost fell on staff and patient.Pictures are attached.The weight of the monitor and arm seems to exceed the allowable weight of the design.Equipment info: hologic insight fd sn (b)(4), install date: 2018.Fda safety report id# (b)(4).

• Brand Name: HOLOGIC INSIGHT FD
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 13847531
• MDR Text Key: 287785940
• Report Number: MW5108386
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/17/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention