MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC MAMMOGRAPY MACHINE; SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number CE 090-CE0001233

Device Problems Communication or Transmission Problem (2896); Mechanics Altered (2984); Unexpected Shutdown (4019)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

During mammography imaging communication error after 3rd image.The compression did not release and tower shut off.Manually rose compression then drops down automatically, no compression movement.Compression rotor was not working.Compression rotor replaced.Fda safety report id # (b)(4).

• Brand Name: HOLOGIC MAMMOGRAPY MACHINE
• Type of Device: SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 15690521
• MDR Text Key: 302774065
• Report Number: MW5112923
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE 090-CE0001233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female