HORIZON HORIZON-CI N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-19 for HORIZON HORIZON-CI N/A manufactured by Hologic, Inc.

Event Text Entries

[97910094] It was reported that an error was received while trying to reposition during a patient exam, which required the patient to be re-exposed. It was determined that the c-arm interface board needed to be replaced. Once the board was replaced the system is working as intended.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220984-2018-00082
• MDR Report Key: 7207649
• Report Source: USER FACILITY
• Date Received: 2018-01-19
• Date of Report: 2017-12-21
• Date of Event: 2017-12-21
• Date Mfgr Received: 2017-12-21
• Device Manufacturer Date: 2014-11-10
• Date Added to Maude: 2018-01-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RADIOLOGIC TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KRISTIN FORNIERI
• Manufacturer Street: 36 & 37 APPLE RIDGE ROAD
• Manufacturer City: DANBURY CT 06810
• Manufacturer Country: US
• Manufacturer Postal: 06810
• Manufacturer Phone: 2037318491
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HORIZON
• Generic Name: DENSITOMETER, BONE
• Product Code: KGI
• Date Received: 2018-01-19
• Model Number: HORIZON-CI
• Catalog Number: N/A
• Lot Number: N/A
• Operator: RADIOLOGIC TECHNOLOGIST
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOLOGIC, INC
• Manufacturer Address: 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-01-19